Trial Outcomes & Findings for Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events) (NCT NCT01327846)

NCT ID: NCT01327846

Last Updated: 2020-01-22

Results Overview

Time to occurrence of CEC (Cardiovascular clinical events adjudication committee) confirmed MACE, which was a composite endpoint consisting of CEC confirmed CV death, CEC confirmed non-fatal MI,or CEC confirmed non-fatal stroke. Patients with the CEC adjudicated reason for death of "Unknown" were counted as CV (cardiovascular) death.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 10066 participants
• Primary outcome timeframe: From randomization, to end of treatment plus 30 days, up to approximately 6 years
• Results posted on: 2020-01-22

Participant Flow

10066 patients enrolled in the Core phase (4 randomized groups); 5 patients enrolled in the safety set were not included in efficacy set. 5777 patients continued in the Extension phase (539 entered only the washout period, 5238 entered the treatment period(s)). The Core phase completed as planned; "terminated" applies to the Extension phase.

A total of 17482 patients were screened, and 10102 patients completed the screening phase. A total of 6430 patients did not complete the screening phase due to screen failure.

Participant milestones

Measure	Group I Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group II Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group III Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group IV Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
Core Phase STARTED	2263	2284	2170	3344
Core Phase COMPLETED	2235	2252	2144	3311
Core Phase NOT COMPLETED	28	32	26	33
Extension Phase STARTED	1267	1287	1279	1944
Extension Phase Stopped/Discontinued Study at Washout	127	97	137	178
Extension Phase Completed Treatment Period	41	45	49	60
Extension Phase Details Missing	0	1	1	0
Extension Phase COMPLETED	168	143	187	238
Extension Phase NOT COMPLETED	1099	1144	1092	1706

Reasons for withdrawal

Measure	Group I Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group II Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group III Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group IV Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
Core Phase Subject decision (vital status: missing)	1	2	2	1
Core Phase Subject decision (vital stat: unkn)	0	0	3	3
Core Phase Subject decision (vital stat: dead)	1	3	4	4
Core Phase Subject decision (vital stat: alive)	23	24	13	20
Core Phase Lost to Follow-up	3	3	4	5
Extension Phase Study terminated by sponsor	1073	1124	1067	1660
Extension Phase Withdrawal by Subject	20	13	19	37
Extension Phase Lost to Follow-up	4	3	4	7
Extension Phase Technical Problems	2	4	2	2

Baseline Characteristics

FAS

Baseline characteristics by cohort

Measure	Group I n=2263 Participants Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group II n=2284 Participants Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group III n=2170 Participants Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group IV n=3344 Participants Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Total n=10061 Participants Total of all reporting groups
Age, Customized < 65	1424 Participants n=5 Participants • FAS	1428 Participants n=7 Participants • FAS	1350 Participants n=5 Participants • FAS	2089 Participants n=4 Participants • FAS	6291 Participants n=21 Participants • FAS
Age, Customized >= 65	839 Participants n=5 Participants • FAS	856 Participants n=7 Participants • FAS	820 Participants n=5 Participants • FAS	1255 Participants n=4 Participants • FAS	3770 Participants n=21 Participants • FAS
Sex: Female, Male Female	606 Participants n=5 Participants • FAS	575 Participants n=7 Participants • FAS	541 Participants n=5 Participants • FAS	865 Participants n=4 Participants • FAS	2587 Participants n=21 Participants • FAS
Sex: Female, Male Male	1657 Participants n=5 Participants • FAS	1709 Participants n=7 Participants • FAS	1629 Participants n=5 Participants • FAS	2479 Participants n=4 Participants • FAS	7474 Participants n=21 Participants • FAS
Race/Ethnicity, Customized Caucasian	1804 Participants n=5 Participants • FAS	1808 Participants n=7 Participants • FAS	1772 Participants n=5 Participants • FAS	2652 Participants n=4 Participants • FAS	8036 Participants n=21 Participants • FAS
Race/Ethnicity, Customized Black	84 Participants n=5 Participants • FAS	67 Participants n=7 Participants • FAS	61 Participants n=5 Participants • FAS	106 Participants n=4 Participants • FAS	318 Participants n=21 Participants • FAS
Race/Ethnicity, Customized Asian	265 Participants n=5 Participants • FAS	278 Participants n=7 Participants • FAS	232 Participants n=5 Participants • FAS	388 Participants n=4 Participants • FAS	1163 Participants n=21 Participants • FAS
Race/Ethnicity, Customized Native American	47 Participants n=5 Participants • FAS	49 Participants n=7 Participants • FAS	41 Participants n=5 Participants • FAS	82 Participants n=4 Participants • FAS	219 Participants n=21 Participants • FAS
Race/Ethnicity, Customized Pacific Islander	0 Participants n=5 Participants • FAS	0 Participants n=7 Participants • FAS	1 Participants n=5 Participants • FAS	1 Participants n=4 Participants • FAS	2 Participants n=21 Participants • FAS
Race/Ethnicity, Customized Unknown	3 Participants n=5 Participants • FAS	3 Participants n=7 Participants • FAS	1 Participants n=5 Participants • FAS	3 Participants n=4 Participants • FAS	10 Participants n=21 Participants • FAS
Race/Ethnicity, Customized Other	60 Participants n=5 Participants • FAS	79 Participants n=7 Participants • FAS	62 Participants n=5 Participants • FAS	112 Participants n=4 Participants • FAS	313 Participants n=21 Participants • FAS

PRIMARY outcome

Timeframe: From randomization, to end of treatment plus 30 days, up to approximately 6 years

Population: Full Analysis Set (FAS): All randomized patients except for those who were misrandomized or from sites with serious GCP violations

Time to occurrence of CEC (Cardiovascular clinical events adjudication committee) confirmed MACE, which was a composite endpoint consisting of CEC confirmed CV death, CEC confirmed non-fatal MI,or CEC confirmed non-fatal stroke. Patients with the CEC adjudicated reason for death of "Unknown" were counted as CV (cardiovascular) death.

Outcome measures

Measure	Group I n=2263 Participants Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group II n=2284 Participants Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group III n=2170 Participants Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group IV n=3344 Participants Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
Analysis of Core Phase First CEC Confirmed Major Adverse Cardiovascular Events (MACE) and Its Components MACE	322 Participants	320 Participants	313 Participants	535 Participants
Analysis of Core Phase First CEC Confirmed Major Adverse Cardiovascular Events (MACE) and Its Components CV death	151 Participants	144 Participants	137 Participants	235 Participants
Analysis of Core Phase First CEC Confirmed Major Adverse Cardiovascular Events (MACE) and Its Components MI (fatal and non-fatal)	174 Participants	159 Participants	169 Participants	292 Participants
Analysis of Core Phase First CEC Confirmed Major Adverse Cardiovascular Events (MACE) and Its Components MI (non-fatal)	171 Participants	158 Participants	168 Participants	291 Participants
Analysis of Core Phase First CEC Confirmed Major Adverse Cardiovascular Events (MACE) and Its Components Stroke (fatal and non-fatal)	51 Participants	63 Participants	58 Participants	92 Participants
Analysis of Core Phase First CEC Confirmed Major Adverse Cardiovascular Events (MACE) and Its Components Stroke (non-fatal)	51 Participants	63 Participants	58 Participants	91 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Data from subjects were not collected as the substudy was terminated prior to data collection.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From randomization up to approximately 6 years

Population: Data from subjects were not collected as the substudy was terminated prior to data collection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization, to end of treatment pus 30 days, up to approximately 6 years

Population: FAS: All randomized patients except for those who were misrandomized or from sites with serious GCP violations

Occurrence of the composite cardiovascular endpoint consisting of cardiovascular death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina requiring unplanned revascularization.

MACE includes CV death, non-fatal MI and non-fatal stroke. CEC = Clinical Endpoints Committee

Outcome measures

Measure	Group I n=2263 Participants Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group II n=2284 Participants Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group III n=2170 Participants Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group IV n=3344 Participants Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
Patients With Core Phase CEC Confirmed CV Death, Non-fatal MI, Non-fatal Stroke, or Hospitalization for Unstable Angina Requiring Unplanned Revascularization MACE or unstable angina	348 Participants	352 Participants	344 Participants	601 Participants
Patients With Core Phase CEC Confirmed CV Death, Non-fatal MI, Non-fatal Stroke, or Hospitalization for Unstable Angina Requiring Unplanned Revascularization Unstable angina	34 Participants	38 Participants	38 Participants	85 Participants

SECONDARY outcome

Timeframe: From randomization up to approximately 6 years

Population: FAS: All randomized patients except for those who were misrandomized or from sites with serious GCP violations

Time to CEC confirmed new onset of type 2 diabetes among those with pre-diabetes at randomization (i.e. excluding those that are normoglycemic at baseline)

Outcome measures

Measure	Group I n=1132 Participants Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group II n=1094 Participants Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group III n=1089 Participants Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group IV n=1645 Participants Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
Patients With Core Phase New Onset Type 2 Diabetes Among Patients With Pre-diabetes at Randomization	169 Participants	171 Participants	161 Participants	246 Participants

SECONDARY outcome

Timeframe: From randomization, to end of treatment plus 30 days, up to approximately 6 years

Population: FAS: All randomized patients except for those who were misrandomized or from sites with serious GCP violations

Occurrence of the composite endpoint consisting of all-cause mortality, non-fatal IM, or non-fatal stroke

Outcome measures

Measure	Group I n=2263 Participants Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group II n=2284 Participants Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group III n=2170 Participants Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group IV n=3344 Participants Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
Core Phase All-cause Mortality, Non-fatal MI, or Non-fatal Stroke	403 Participants	395 Participants	394 Participants	661 Participants

SECONDARY outcome

Timeframe: From randomization, to end of treatment plus 30 days, up to approximately 6 years

Population: FAS: All randomized patients except for those who were misrandomized or from sites with serious GCP violations

Number of participant deaths

Outcome measures

Measure	Group I n=2263 Participants Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group II n=2284 Participants Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group III n=2170 Participants Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group IV n=3344 Participants Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
Core Phase All-cause Mortality	239 Participants	238 Participants	228 Participants	375 Participants

SECONDARY outcome

Timeframe: From randomization, to end of treatment plus 30 days, up to approximately 6 years

Population: Safety set: All patients who received at least one dose of study treatment and had at least one post-baseline safety assessment

Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring during the double-blind Core phase of the study. AEs/SAEs are any signs or symptoms that occur during the study treatment.

Outcome measures

Measure	Group I n=2263 Participants Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group II n=2285 Participants Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group III n=2170 Participants Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group IV n=3348 Participants Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
Summary of Adverse Events (Core Phase) Patients with at least one AE	1987 Participants	1970 Participants	1872 Participants	2915 Participants
Summary of Adverse Events (Core Phase) AEs suspected to be related tostudy drug	355 Participants	350 Participants	267 Participants	474 Participants
Summary of Adverse Events (Core Phase) Patients with at least one SAE	836 Participants	812 Participants	741 Participants	1204 Participants
Summary of Adverse Events (Core Phase) Discontinued due to SAEs	135 Participants	130 Participants	117 Participants	198 Participants
Summary of Adverse Events (Core Phase) Discontinued due to non-seriousAEs	40 Participants	34 Participants	26 Participants	47 Participants
Summary of Adverse Events (Core Phase) AEs leading to study treatmentinterruption	268 Participants	270 Participants	228 Participants	399 Participants

SECONDARY outcome

Timeframe: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years

Population: Extension Safety set: All patients who received at least one dose of study treatment during the Core Phase and who entered the Extension phase.

Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring during the Extension phase of the study. AEs/SAEs are any signs or symptoms that occur during the study treatment.

Outcome measures

Measure	Group I n=1267 Participants Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group II n=1287 Participants Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group III n=1279 Participants Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group IV n=1944 Participants Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
Summary of Adverse Events (Extension Phase) Patients with at least one SAE	310 Participants	326 Participants	322 Participants	465 Participants
Summary of Adverse Events (Extension Phase) Discontinued due to SAEs	67 Participants	71 Participants	71 Participants	98 Participants
Summary of Adverse Events (Extension Phase) Discontinued due to non-seriousAEs	8 Participants	6 Participants	12 Participants	8 Participants
Summary of Adverse Events (Extension Phase) AEs leading to study treatmentinterruption	59 Participants	72 Participants	62 Participants	100 Participants
Summary of Adverse Events (Extension Phase) Patients with at least one AE	788 Participants	845 Participants	793 Participants	1250 Participants
Summary of Adverse Events (Extension Phase) AEs suspected to be related tostudy drug	40 Participants	34 Participants	43 Participants	65 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Data from subjects were not collected as the substudy was terminated prior to data collection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: Data from subjects were not collected as the substudy was terminated prior to data collection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: Data from subjects were not collected as the substudy was terminated prior to data collection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: Data from subjects were not collected as the substudy was terminated prior to data collection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization up to approximately 6 years

Population: Data from subjects were not collected as the substudy was terminated prior to data collection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization up to approximately 6 years

Population: Data from subjects were not collected as the substudy was terminated prior to data collection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization up to approximately 6 years

Population: Data from subjects were not collected as the substudy was terminated prior to data collection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization up to approximately 6 years

Population: Data from subjects were not collected as the substudy was terminated prior to data collection.

Outcome measures

Outcome data not reported

Adverse Events

Group I

Serious events: 759 serious events

Other events: 1271 other events

Deaths: 239 deaths

Group II

Serious events: 743 serious events

Other events: 1324 other events

Deaths: 240 deaths

Group III

Serious events: 686 serious events

Other events: 1199 other events

Deaths: 228 deaths

Group IV

Serious events: 1099 serious events

Other events: 1905 other events

Deaths: 378 deaths

Group V

Serious events: 1216 serious events

Other events: 1497 other events

Deaths: 211 deaths

Serious adverse events

Measure	Group I n=2263 participants at risk Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group II n=2285 participants at risk Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group III n=2170 participants at risk Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group IV n=3348 participants at risk Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group V n=5777 participants at risk Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy.
Cardiac disorders Microvascular coronary artery disease	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Mitral valve incompetence	0.22% 5/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Myocardial infarction	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.23% 5/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.73% 42/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Ear and labyrinth disorders Presbyacusis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Myocardial ischaemia	0.27% 6/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.23% 5/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 6/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.17% 10/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Nodal arrhythmia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Palpitations	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Pericardial effusion	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Pericarditis	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Prinzmetal angina	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Pulseless electrical activity	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Right ventricular dysfunction	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Right ventricular failure	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Silent myocardial infarction	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Sinus arrest	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Sinus bradycardia	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Sinus node dysfunction	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.23% 5/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.10% 6/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Sinus tachycardia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Stress cardiomyopathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Supraventricular tachycardia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Tachyarrhythmia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Tachycardia	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Torsade de pointes	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Tricuspid valve incompetence	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Trifascicular block	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Ventricular arrhythmia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Ventricular extrasystoles	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Ventricular fibrillation	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.39% 9/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.21% 7/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 7/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Ventricular tachyarrhythmia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Ventricular tachycardia	0.44% 10/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.22% 5/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.41% 9/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.48% 16/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.31% 18/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Congenital, familial and genetic disorders Atrial septal defect	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Congenital, familial and genetic disorders Branchial cyst	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Congenital, familial and genetic disorders Cerebrovascular arteriovenous malformation	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Congenital, familial and genetic disorders Haemorrhagic arteriovenous malformation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Congenital, familial and genetic disorders Hereditary haemochromatosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Congenital, familial and genetic disorders Nonketotic hyperglycinaemia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Congenital, familial and genetic disorders Phimosis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Congenital, familial and genetic disorders Pyloric stenosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Congenital, familial and genetic disorders Tracheo-oesophageal fistula	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Ear and labyrinth disorders Cerumen impaction	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Ear and labyrinth disorders Ear pain	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Ear and labyrinth disorders Hypoacusis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Ear and labyrinth disorders Meniere's disease	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Ear and labyrinth disorders Otosclerosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Ear and labyrinth disorders Vertigo	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.22% 5/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Ear and labyrinth disorders Vertigo positional	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Endocrine disorders Goitre	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Endocrine disorders Hyperparathyroidism primary	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Endocrine disorders Hyperthyroidism	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Endocrine disorders Hypopituitarism	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Endocrine disorders Hypothyroidism	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Endocrine disorders Primary hyperaldosteronism	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Endocrine disorders Toxic goitre	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Amaurosis fugax	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Angle closure glaucoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Blindness	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Blindness transient	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Blindness unilateral	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Cataract	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.35% 8/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.23% 5/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.36% 12/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 8/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Cataract cortical	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Cataract diabetic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Cataract nuclear	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Corneal degeneration	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Corneal infiltrates	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Dacryostenosis acquired	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Diabetic retinopathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Eye haemorrhage	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Eyelid ptosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Glaucoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Iridocyclitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Lens dislocation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Macular degeneration	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Macular fibrosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Macular hole	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Macular oedema	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Neovascular age-related macular degeneration	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Ocular ischaemic syndrome	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Papilloedema	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Retinal artery thrombosis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Retinal detachment	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Retinal haemorrhage	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Retinal vein occlusion	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Retinal vein thrombosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Eye disorders Vitreous haemorrhage	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Abdominal adhesions	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Abdominal distension	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Abdominal hernia	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Abdominal pain	0.31% 7/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.46% 10/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.30% 10/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.10% 6/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Abdominal pain upper	0.27% 6/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Acute abdomen	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Alcoholic pancreatitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Anal fissure	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Anal skin tags	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Anal ulcer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Anal ulcer haemorrhage	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Anorectal disorder	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Appendiceal mucocoele	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Appendix disorder	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Ascites	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Change of bowel habit	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Chronic gastritis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Colitis	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Colitis ischaemic	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Colitis microscopic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Colitis ulcerative	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Colonic fistula	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Constipation	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Crohn's disease	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Dental caries	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Diabetic gastroenteropathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Diarrhoea	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.22% 5/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Dieulafoy's vascular malformation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Diverticulum	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Duodenal stenosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Duodenal ulcer	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Duodenal ulcer perforation	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Duodenitis	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Dyspepsia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Dysphagia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Enteritis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Enterocolitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Enterovesical fistula	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Erosive duodenitis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Faecaloma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Faeces discoloured	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Flatulence	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Food poisoning	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Gallstone ileus	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Gastric ulcer	0.31% 7/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.26% 6/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Gastric ulcer perforation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Gastric volvulus	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Gastritis	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 6/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Gastritis erosive	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Gastritis haemorrhagic	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Gastroduodenitis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Gastrointestinal angiodysplasia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Gastrointestinal disorder	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Gastrointestinal erosion	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.57% 13/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.70% 16/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.65% 14/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.39% 13/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 5/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Gastrointestinal necrosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Gastrointestinal perforation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Gastrointestinal ulcer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Gastrointestinal vascular malformation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.22% 5/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Haematemesis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Haematochezia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Haemorrhagic necrotic pancreatitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Haemorrhoids	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Haemorrhoids thrombosed	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Hiatus hernia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Ileal ulcer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Ileus	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Ileus paralytic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Incarcerated inguinal hernia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Incarcerated umbilical hernia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Inflammatory bowel disease	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Inguinal hernia	0.35% 8/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.22% 5/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.32% 7/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.21% 7/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 8/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Inguinal hernia strangulated	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Intestinal fistula	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Intestinal haemorrhage	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Intestinal infarction	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Intestinal mass	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Intestinal obstruction	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Intestinal perforation	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Intestinal ulcer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Ischaemic enteritis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Large intestinal obstruction	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Large intestinal stenosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Large intestine perforation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Large intestine polyp	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.36% 12/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.10% 6/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Mallory-Weiss syndrome	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Melaena	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Mesenteric artery stenosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Mesenteric artery thrombosis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Mesenteric vascular insufficiency	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Mouth cyst	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Mouth ulceration	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Narcotic bowel syndrome	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Nausea	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Obstruction gastric	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Odynophagia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Oesophageal obstruction	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Oesophageal perforation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Oesophageal rupture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Oesophageal ulcer	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Oesophagitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Pancreatic cyst	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Pancreatic disorder	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Pancreatic duct dilatation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Pancreatic mass	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Pancreatic pseudocyst	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Pancreatitis	0.27% 6/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.26% 6/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.33% 11/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Pancreatitis acute	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.26% 6/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.10% 6/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Pancreatitis necrotising	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Peptic ulcer	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Peptic ulcer haemorrhage	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Peritoneal haemorrhage	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Pneumatosis intestinalis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Pneumoperitoneum	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Proctalgia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Proctitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Ranula	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Rectal haemorrhage	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.26% 6/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Rectal lesion	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Rectal perforation	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Rectal polyp	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Retroperitoneal haematoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Salivary gland calculus	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Small intestinal obstruction	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.16% 9/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Small intestine ulcer	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Subileus	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Thrombosis mesenteric vessel	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Umbilical hernia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.35% 8/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.37% 8/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.24% 8/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Vomiting	0.22% 5/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Adverse drug reaction	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Asthenia	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Cardiac death	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Chest discomfort	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Chest pain	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.53% 12/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.27% 9/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.16% 9/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Chills	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Complication associated with device	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Death	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.21% 12/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Drowning	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Drug intolerance	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Exercise tolerance decreased	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Facial pain	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Fatigue	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Gait disturbance	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders General physical health deterioration	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Generalised oedema	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Hernia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Heteroplasia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Hyperplasia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Hypothermia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Impaired healing	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Implant site irritation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Incarcerated hernia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Inflammation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Influenza like illness	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Injection site reaction	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Ischaemic ulcer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Local swelling	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Malaise	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Mass	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Multiple organ dysfunction syndrome	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.10% 6/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Necrosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Non-cardiac chest pain	1.9% 44/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	2.1% 48/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.8% 39/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	2.2% 75/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.61% 35/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Oedema peripheral	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Pacemaker syndrome	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Pain	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Polyp	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Pseudocyst	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Pyrexia	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.28% 6/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.15% 5/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Stent-graft endoleak	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Sudden cardiac death	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.19% 11/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Sudden death	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 7/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Surgical failure	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Systemic inflammatory response syndrome	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Vascular stent restenosis	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Vascular stent stenosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Vascular stent thrombosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Vessel puncture site haemorrhage	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Acute hepatic failure	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Alcoholic liver disease	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Bile duct stone	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Biliary cirrhosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Biliary colic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Biliary dilatation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Biliary fistula	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Cholangitis	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Cholangitis acute	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Cholecystitis	0.49% 11/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.37% 8/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.27% 9/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 7/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Cholecystitis acute	0.22% 5/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.31% 7/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.21% 7/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 5/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Cholelithiasis	0.35% 8/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.35% 8/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.37% 8/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.54% 18/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Cholestasis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Gallbladder polyp	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Haemorrhagic hepatic cyst	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Hepatic cirrhosis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Hepatic congestion	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Hepatic failure	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Hepatic function abnormal	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Hepatic vein thrombosis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Hepatitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Hepatitis toxic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Hepatomegaly	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Hepatorenal failure	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Hepatosplenomegaly	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Hydrocholecystis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Ischaemic hepatitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Liver disorder	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Liver injury	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Non-alcoholic fatty liver	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Non-alcoholic steatohepatitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Hepatobiliary disorders Steatohepatitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Immune system disorders Allergy to arthropod sting	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Immune system disorders Anaphylactic reaction	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Immune system disorders Anaphylactic shock	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Immune system disorders Contrast media allergy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Immune system disorders Drug hypersensitivity	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Immune system disorders Hypersensitivity	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Abdominal abscess	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Abdominal infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Abdominal sepsis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Abscess intestinal	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Abscess jaw	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Abscess limb	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Abscess neck	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Abscess oral	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Abscess soft tissue	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Acute hepatitis B	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Acute sinusitis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Anal abscess	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Appendicitis	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.28% 6/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Appendicitis perforated	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Arthritis bacterial	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Arthritis infective	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Atypical pneumonia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Bacteraemia	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Bacterial disease carrier	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Bacterial pyelonephritis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Bacterial sepsis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Bacteroides infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Bartholin's abscess	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Beta haemolytic streptococcal infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Bone abscess	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Bronchitis	0.44% 10/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.39% 9/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.28% 6/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.42% 14/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.17% 10/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Bronchitis bacterial	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Bursitis infective	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Bursitis infective staphylococcal	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Campylobacter gastroenteritis	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Campylobacter infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Candida infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Carbuncle	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Cellulitis	1.3% 29/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.4% 32/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.88% 19/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.81% 27/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.38% 22/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Cellulitis gangrenous	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Cellulitis of male external genital organ	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Cellulitis staphylococcal	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Central nervous system infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Chikungunya virus infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Cholangitis infective	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Cholecystitis infective	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Chorioretinitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Chronic sinusitis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Chronic tonsillitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Clostridial infection	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Clostridium difficile colitis	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Clostridium difficile infection	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Colonic abscess	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Conjunctivitis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Corona virus infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Creutzfeldt-Jakob disease	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Cystitis	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Dengue fever	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Device related infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Device related sepsis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Diabetic foot infection	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Diabetic gangrene	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Diarrhoea infectious	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Diverticulitis	0.35% 8/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.39% 9/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.37% 8/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.39% 13/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.10% 6/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Ear infection	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Empyema	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Endocarditis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Endocarditis bacterial	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Enteritis infectious	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Epididymitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Epiglottitis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Erysipelas	0.27% 6/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.53% 12/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.28% 6/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.27% 9/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.23% 13/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Escherichia sepsis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Escherichia urinary tract infection	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations External ear cellulitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Folliculitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Fungal skin infection	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Furuncle	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Gallbladder abscess	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Gallbladder empyema	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Gangrene	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.23% 5/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Gastritis viral	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Gastroenteritis	0.27% 6/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.22% 5/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.28% 6/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.24% 8/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Gastroenteritis clostridial	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Gastroenteritis rotavirus	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Gastroenteritis salmonella	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Gastroenteritis viral	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Gastrointestinal bacterial infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Gastrointestinal infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Gastrointestinal viral infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Groin infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Haematoma infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Haemophilus infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Haemophilus sepsis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Haemorrhagic pneumonia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Helicobacter infection	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Hepatic amoebiasis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Hepatitis viral	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Herpes ophthalmic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Herpes zoster	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Human ehrlichiosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Hypopyon	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Implant site abscess	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Implant site infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Incision site cellulitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Incision site infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Infected bite	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Infected cyst	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Infected skin ulcer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Infectious colitis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Infectious pleural effusion	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.22% 5/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Infective spondylitis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Influenza	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.26% 6/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.16% 9/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Intervertebral discitis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Joint abscess	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Labyrinthitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Leptospirosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Liver abscess	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Localised infection	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.15% 5/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Lower respiratory tract infection	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Lung abscess	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Lung infection	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Lyme disease	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Lymphangitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Malaria	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Mastoiditis	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Mediastinitis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Medical device site infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Meningitis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Meningitis bacterial	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Meningococcal sepsis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Mesenteric abscess	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Metapneumovirus infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Muscle abscess	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Mycobacterial infection	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Mycobacterium avium complex infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Necrotising fasciitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Neutropenic sepsis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Oesophageal candidiasis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Orchitis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Osteomyelitis	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.17% 10/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Osteomyelitis bacterial	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Osteomyelitis blastomyces	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Otitis externa	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Otitis media	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Otitis media acute	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Otitis media chronic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pancreatic abscess	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Parainfluenzae virus infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Parametritis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Paronychia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Parotitis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pelvic abscess	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Perichondritis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Perineal abscess	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Periodontitis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Periorbital cellulitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Perirectal abscess	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Peritoneal abscess	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Peritonitis	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pharyngeal abscess	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pharyngitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pharyngitis streptococcal	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pilonidal cyst	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pneumococcal sepsis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pneumonia	3.0% 67/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	2.6% 60/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	2.4% 53/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	2.5% 83/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.2% 70/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pneumonia bacterial	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pneumonia escherichia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pneumonia haemophilus	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pneumonia klebsiella	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pneumonia legionella	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pneumonia necrotising	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pneumonia pneumococcal	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pneumonia pseudomonal	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pneumonia staphylococcal	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Post procedural cellulitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Post procedural infection	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Post procedural sepsis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Postoperative abscess	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Postoperative wound infection	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Proctitis infectious	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Propionibacterium infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pseudomembranous colitis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pseudomonal bacteraemia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pseudomonas bronchitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pseudomonas infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Psoas abscess	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pulmonary sepsis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pulmonary tuberculosis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pyelitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pyelonephritis	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.15% 5/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pyelonephritis acute	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.22% 5/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pyoderma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Pyuria	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Renal abscess	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Respiratory tract infection	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.31% 7/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.21% 7/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Respiratory tract infection viral	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Rhinitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Rubella	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Salmonellosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Scrotal abscess	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Scrub typhus	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Sepsis	0.84% 19/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.1% 25/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.69% 15/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.57% 19/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.38% 22/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Sepsis syndrome	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Septic embolus	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Septic necrosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Septic shock	0.27% 6/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.35% 8/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.28% 6/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.33% 11/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Sialoadenitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Sinusitis	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Sinusitis fungal	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Staphylococcal abscess	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Staphylococcal bacteraemia	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Staphylococcal infection	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Staphylococcal mediastinitis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Staphylococcal sepsis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Streptococcal bacteraemia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Streptococcal sepsis	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Subcutaneous abscess	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Subdiaphragmatic abscess	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Subdural empyema	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Testicular abscess	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Tetanus	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Tonsillitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Tooth abscess	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Tracheobronchitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Tuberculosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Upper respiratory tract infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Urinary tract infection	0.57% 13/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.48% 11/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.46% 10/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.63% 21/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.33% 19/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Urinary tract infection bacterial	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Ejection fraction decreased	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Urinary tract infection enterococcal	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Urinary tract infection fungal	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Urinary tract infection pseudomonal	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Urosepsis	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.23% 5/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 7/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Vestibular neuronitis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Viral cardiomyopathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Viral diarrhoea	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Viral infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Viral upper respiratory tract infection	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Vulval abscess	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Wound infection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Wound infection bacterial	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Wound infection staphylococcal	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Wound sepsis	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Abdominal injury	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Accident	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Anaemia postoperative	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Anastomotic leak	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Animal bite	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Ankle fracture	0.22% 5/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Arterial injury	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Asbestosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Bone contusion	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Brain contusion	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Cardiac function disturbance postoperative	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Central cord syndrome	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Chest injury	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Clavicle fracture	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Closed globe injury	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Comminuted fracture	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Concussion	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Contusion	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.15% 5/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Coronary artery restenosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Craniocerebral injury	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Dural tear	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Epicondylitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Face injury	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Fall	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.16% 9/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Femoral neck fracture	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.22% 5/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.15% 5/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Femur fracture	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.15% 5/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Foot fracture	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Forearm fracture	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Foreign body	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Fracture displacement	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Gallbladder injury	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Gastrointestinal stoma necrosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Head injury	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Hip fracture	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 6/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Incision site haemorrhage	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Incision site pain	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Incisional hernia, obstructive	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Injury	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Intentional product misuse	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Joint dislocation	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Joint injury	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Laceration	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Ligament injury	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Limb injury	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Limb traumatic amputation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Lower limb fracture	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.23% 5/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.24% 8/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Multiple fractures	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Multiple injuries	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Muscle contusion	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Musculoskeletal foreign body	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Nerve injury	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Overdose	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Pelvic fracture	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Peripheral artery restenosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Periprosthetic fracture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Perirenal haematoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Pneumoconiosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Pneumothorax traumatic	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Post procedural discharge	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Post procedural fever	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Post procedural haematoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Postoperative hernia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Postoperative wound complication	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Procedural complication	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Procedural intestinal perforation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Pubis fracture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Radiation mucositis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Rib fracture	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.21% 7/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Road traffic accident	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Scapula fracture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Scratch	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Seroma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Skeletal injury	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Spinal column injury	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.15% 5/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Spinal cord injury	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Spinal cord injury cervical	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Spinal fracture	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Splenic rupture	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Stab wound	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Stress fracture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Subdural haematoma	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.15% 5/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 5/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Subdural haemorrhage	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Tendon rupture	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Toxicity to various agents	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Tracheal haemorrhage	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Traumatic amputation	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Traumatic arthritis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Traumatic haemothorax	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Upper limb fracture	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Urinary retention postoperative	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Vascular graft complication	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Vascular pseudoaneurysm ruptured	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Wound dehiscence	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Wound secretion	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Alanine aminotransferase increased	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Anticoagulation drug level above therapeutic	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Aspartate aminotransferase increased	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Blood creatine phosphokinase MB increased	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Blood creatine phosphokinase increased	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Blood creatinine increased	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Blood glucose increased	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Blood magnesium decreased	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Blood pressure increased	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Blood urine present	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Body mass index decreased	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Central venous pressure increased	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Chest X-ray abnormal	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Clostridium test positive	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Haemoglobin decreased	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Hepatic enzyme increased	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Human metapneumovirus test positive	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Imaging procedure abnormal	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations International normalised ratio decreased	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations International normalised ratio increased	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Liver function test abnormal	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Liver function test increased	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations N-terminal prohormone brain natriuretic peptide increased	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Oxygen saturation decreased	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Platelet count decreased	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Quality of life decreased	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Scan myocardial perfusion abnormal	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Troponin T increased	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Troponin increased	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Volume blood decreased	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Weight decreased	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations Weight increased	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Investigations White blood cell count increased	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Acidosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Cachexia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Dehydration	0.22% 5/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.26% 6/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.28% 6/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 6/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 8/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Diabetes mellitus	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.44% 10/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.33% 11/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 8/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.32% 7/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Diabetes with hyperosmolarity	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Diabetic complication	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Fluid overload	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Gout	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Hyperammonaemia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Hyperchloraemia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Hyperglycaemia	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 6/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Hyperkalaemia	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 7/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Hypoglycaemia	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.27% 9/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Hypokalaemia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.27% 9/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Hypomagnesaemia	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Hypovolaemia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Insulin resistant diabetes	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Insulin-requiring type 2 diabetes mellitus	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Ketoacidosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Lactic acidosis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Malnutrition	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Metabolic acidosis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Obesity	0.22% 5/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Arthralgia	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.22% 5/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.10% 6/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Arthritis	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Arthritis reactive	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Back pain	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.35% 8/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.23% 5/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.21% 7/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.10% 6/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Chondromalacia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Chondropathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Dactylitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Exostosis	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Fasciitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Finger deformity	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Flank pain	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Foot deformity	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Fracture malunion	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Gouty tophus	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Immunoglobulin G4 related disease	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Intervertebral disc calcification	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Intervertebral disc compression	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Intervertebral disc displacement	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.28% 6/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.30% 10/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.10% 6/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Jaw cyst	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Joint instability	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.15% 5/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 5/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Meniscal degeneration	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Metatarsalgia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Muscle atrophy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Muscle spasms	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Muscle swelling	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.23% 5/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.15% 5/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Myalgia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Myofascial pain syndrome	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Neck pain	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.84% 19/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.92% 21/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.83% 18/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.5% 51/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.45% 26/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Osteolysis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Pain in extremity	0.22% 5/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Pain in jaw	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Pathological fracture	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.15% 5/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Shoulder deformity	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Soft tissue mass	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.27% 6/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Spinal deformity	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Spinal pain	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.15% 5/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Spondylitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Vertebral wedging	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Abdominal neoplasm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute leukaemia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.15% 5/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenosquamous cell lung cancer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal neoplasm	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiolipoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiosarcoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.62% 14/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.79% 18/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.83% 18/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.63% 21/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.52% 30/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign cardiac neoplasm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign gastric neoplasm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of scrotum	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of skin	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign salivary gland neoplasm	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign small intestinal neoplasm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign urinary tract neoplasm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.22% 5/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.22% 5/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.15% 5/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder papilloma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer metastatic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.23% 5/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brenner tumour	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour of the gastrointestinal tract	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.23% 5/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 6/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma stage IV	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ductal adenocarcinoma of pancreas	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer stage III	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Extranodal marginal zone B-cell lymphoma (MALT type)	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibrous histiocytoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder adenocarcinoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric adenoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.22% 5/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.15% 5/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 5/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal tract adenoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer stage IV	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypergammaglobulinaemia benign monoclonal	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Inflammatory pseudotumour	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal adenocarcinoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive breast carcinoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Keratoacanthoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large intestine benign neoplasm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo maligna	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip squamous cell carcinoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liposarcoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.21% 7/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage III	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage IV	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified recurrent	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage III	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.39% 9/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.41% 9/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.75% 25/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.24% 14/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma metastatic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoproliferative disorder	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Dementia with Lewy bodies	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant fibrous histiocytoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant mediastinal neoplasm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.22% 5/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of pleura	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of unknown primary site	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant peritoneal neoplasm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mantle cell lymphoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medullary thyroid cancer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma benign	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to adrenals	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to kidney	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.22% 5/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.23% 5/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to pelvis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to pleura	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to rectum	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic bronchial carcinoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Monoclonal gammopathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mucinous adenocarcinoma of appendix	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mycosis fungoides	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelofibrosis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasal cavity cancer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm skin	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine breast tumour	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma refractory	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage IV	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma stage II	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal cancer metastatic	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal neoplasm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oligodendroglioma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal squamous cell carcinoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian neoplasm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.15% 5/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary cystadenoma lymphomatosum	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary renal cell carcinoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penile cancer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Phaeochromocytoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pharyngeal cancer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleomorphic adenoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Polycythaemia vera	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.53% 12/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.44% 10/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.46% 10/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.39% 13/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.26% 15/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer metastatic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer metastatic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.23% 5/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal oncocytoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rosai-Dorfman syndrome	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland adenoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland neoplasm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.15% 5/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine adenocarcinoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma metastatic	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.53% 12/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.22% 5/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.28% 6/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.30% 10/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.16% 9/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.22% 5/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the hypopharynx	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Superficial spreading melanoma stage II	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testis cancer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Throat cancer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer metastatic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer metastatic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma urethra	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour perforation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Amnesia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Amyotrophic lateral sclerosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Aphasia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Apraxia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Ataxia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Balance disorder	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Brain injury	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Brain oedema	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Carotid arteriosclerosis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Carotid artery aneurysm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Carotid artery disease	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Carotid artery occlusion	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Carotid artery stenosis	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 8/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Carpal tunnel syndrome	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Cauda equina syndrome	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Cerebellar infarction	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Cerebellar stroke	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Cerebral arteriosclerosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Cerebral haemorrhage	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Cerebral infarction	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.16% 9/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Cerebral ischaemia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Cerebrovascular accident	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.38% 22/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Cervical myelopathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Cervical radiculopathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Cervicobrachial syndrome	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Cognitive disorder	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Coma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Dementia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Dementia Alzheimer's type	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Depressed level of consciousness	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Diabetic coma	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Diabetic neuropathy	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Diplegia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Dizziness	0.27% 6/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.21% 7/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Dysaesthesia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Dysarthria	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Dystonia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Embolic stroke	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Encephalopathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Epilepsy	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Facial paralysis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Focal dyscognitive seizures	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Guillain-Barre syndrome	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Haemorrhage intracranial	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Haemorrhagic stroke	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Haemorrhagic transformation stroke	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Headache	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Hemiparesis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Hydrocephalus	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Hypersomnia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Hypertensive encephalopathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Hypoaesthesia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Hypoglycaemic coma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Hypoglycaemic encephalopathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders IIIrd nerve paresis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Intracranial aneurysm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Intracranial pressure increased	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Ischaemic stroke	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.28% 16/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Lacunar infarction	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Lacunar stroke	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Loss of consciousness	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Lumbar radiculopathy	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Lumbosacral radiculopathy	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Mental impairment	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Metabolic encephalopathy	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Migraine	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Mixed dementia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Nerve compression	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Neuralgia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Neuropathy peripheral	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Normal pressure hydrocephalus	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Optic neuritis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Orthostatic intolerance	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Paraesthesia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Paralysis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Paresis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Partial seizures	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Peripheral nerve lesion	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Polyneuropathy	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Post herpetic neuralgia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Post stroke seizure	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Presyncope	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Restless legs syndrome	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Sciatica	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.23% 5/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Seizure	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Sensory disturbance	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Spinal claudication	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Spinal cord compression	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Spinal cord infarction	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Spondylitic myelopathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Status epilepticus	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Stupor	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Subdural hygroma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Syncope	0.66% 15/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.74% 17/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.74% 16/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.75% 25/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.28% 16/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Tension headache	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Thalamic infarction	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Thrombotic cerebral infarction	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Tonic convulsion	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Toxic encephalopathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Transient global amnesia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Transient ischaemic attack	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.26% 15/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Trigeminal neuralgia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Upper motor neurone lesion	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders VIth nerve paralysis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Vascular dementia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Vascular encephalopathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Vertebrobasilar insufficiency	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Product Issues Device battery issue	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Product Issues Device dislocation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Product Issues Device end of service	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Product Issues Device failure	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Product Issues Device inappropriate shock delivery	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Product Issues Device issue	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Product Issues Device lead damage	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Product Issues Device lead issue	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Product Issues Device loosening	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Product Issues Device malfunction	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Product Issues Device occlusion	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Product Issues Device signal detection issue	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Product Issues Lead dislodgement	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Acute stress disorder	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Adjustment disorder	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Affective disorder	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Alcoholic psychosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Alcoholism	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Anxiety	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Anxiety disorder	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Anxiety disorder due to a general medical condition	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Bipolar I disorder	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Bipolar disorder	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Burnout syndrome	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Completed suicide	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Confusional state	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Conversion disorder	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Delirium	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Delirium tremens	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Depression	0.31% 7/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Dissociative amnesia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Drug use disorder	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Generalised anxiety disorder	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Hallucination, visual	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Head banging	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Homicidal ideation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Insomnia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Intentional self-injury	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Major depression	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Mental status changes	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 6/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Panic attack	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Personality change	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Psychotic disorder	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Psychotic disorder due to a general medical condition	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Restlessness	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Schizophrenia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Somnambulism	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Suicidal ideation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Psychiatric disorders Suicide attempt	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Acute kidney injury	0.88% 20/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.3% 30/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.74% 16/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.81% 27/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.38% 22/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Acute prerenal failure	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Anuria	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Azotaemia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Calculus bladder	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Calculus urethral	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Calculus urinary	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Chronic kidney disease	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.22% 5/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 5/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Diabetic nephropathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Dysuria	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders End stage renal disease	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Focal segmental glomerulosclerosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Glomerulonephritis membranous	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Haematuria	0.22% 5/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.26% 6/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.21% 7/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Hydronephrosis	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Hypertensive nephropathy	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Lower urinary tract symptoms	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Nephrolithiasis	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.21% 7/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Obstructive uropathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Pollakiuria	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Polyuria	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Prerenal failure	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Renal artery stenosis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Renal artery thrombosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Renal colic	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Renal cyst	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Renal failure	0.31% 7/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.44% 10/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.51% 11/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.39% 13/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 5/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Renal haematoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Renal impairment	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Renal injury	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Renal mass	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Stress urinary incontinence	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Tubulointerstitial nephritis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Ureteric obstruction	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Ureteric stenosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Ureterolithiasis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.21% 7/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Urethral obstruction	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Urinary bladder haemorrhage	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Urinary bladder polyp	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Urinary incontinence	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Urinary retention	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.10% 6/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Renal and urinary disorders Vesicocutaneous fistula	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Balanoposthitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.22% 5/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.26% 6/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.23% 5/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.15% 5/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 8/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Cystocele	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Endometrial hyperplasia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Epididymal cyst	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Genital atrophy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Genital prolapse	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Menorrhagia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Pelvic pain	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Prostatic haemorrhage	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Prostatic mass	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Prostatism	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Prostatitis	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Rectocele	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Spermatocele	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Uterine cervix stenosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Uterine prolapse	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Vaginal haemorrhage	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Varicocele	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Reproductive system and breast disorders Varicose veins pelvic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.44% 10/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.31% 7/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.51% 11/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.39% 13/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.36% 21/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Alveolitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Alveolitis allergic	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Asthma	0.31% 7/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Cheyne-Stokes respiration	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.22% 5/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.23% 5/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.2% 28/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.92% 21/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.74% 16/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.2% 40/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.57% 33/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Cough	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.62% 14/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.35% 8/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.46% 10/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.69% 23/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.33% 19/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea paroxysmal nocturnal	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 6/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Hypopnoea	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 5/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Idiopathic interstitial pneumonia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Idiopathic pneumonia syndrome	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Lung hernia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Nasal turbinate hypertrophy	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Pickwickian syndrome	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Pleural adhesion	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.35% 8/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.22% 5/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 6/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.22% 5/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.31% 18/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Pulmonary haematoma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Pulmonary microemboli	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 5/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Pulmonary sarcoidosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Respiratory alkalosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.53% 12/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.48% 11/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.41% 9/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.36% 12/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 5/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Respiratory tract inflammation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Respiratory tract irritation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Sinus polyp	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.15% 5/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Vocal cord leukoplakia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Acne	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Angioedema	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Blister	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Brow ptosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Diabetic foot	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.26% 6/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Eczema	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Hypersensitivity vasculitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Neurodermatitis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Prurigo	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Pruritus allergic	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Psoriasis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Rhinophyma	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Social circumstances Homicide	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Accelerated hypertension	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Aneurysm ruptured	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Angiodysplasia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Aortic aneurysm	0.35% 8/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.28% 6/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 6/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.21% 12/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Aortic aneurysm rupture	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Aortic dissection	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Aortic stenosis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Aortitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Arterial haemorrhage	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Arterial insufficiency	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Arteriosclerosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 5/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Arteriovenous fistula	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Arteritis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Brachiocephalic artery stenosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Circulatory collapse	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Deep vein thrombosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 5/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Embolism	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Embolism arterial	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Embolism venous	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Essential hypertension	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Extremity necrosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Femoral artery aneurysm	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Femoral artery embolism	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Haematoma	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.15% 5/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 5/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Haemodynamic instability	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Haemorrhage	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Hypertension	0.44% 10/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.35% 8/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.37% 8/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.45% 15/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.29% 17/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Hypertensive crisis	0.31% 7/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.22% 5/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.33% 11/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 5/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Hypertensive emergency	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Hypotension	0.35% 8/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.22% 5/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.33% 11/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.10% 6/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Hypovolaemic shock	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Intermittent claudication	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Internal haemorrhage	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Ischaemic limb pain	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Lymphatic fistula	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Lymphorrhoea	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Malignant hypertension	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Orthostatic hypertension	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Orthostatic hypotension	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Pallor	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Peripheral arterial occlusive disease	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.19% 11/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Peripheral artery aneurysm	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Peripheral artery occlusion	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Peripheral artery stenosis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.10% 6/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Peripheral artery thrombosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Peripheral embolism	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Peripheral ischaemia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.19% 11/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Peripheral vascular disorder	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Peripheral venous disease	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Shock	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Shock haemorrhagic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Temporal arteritis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Thrombophlebitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Thrombophlebitis superficial	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Thrombosis	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Varicose ulceration	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Varicose vein	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Vascular insufficiency	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Venous thrombosis limb	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Abnormal clotting factor	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Anaemia	0.66% 15/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.44% 10/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.42% 14/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.17% 10/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Bone marrow oedema	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.23% 5/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Hilar lymphadenopathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Histiocytosis haematophagic	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Hypochromic anaemia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Leukopenia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Microcytic anaemia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Monoclonal B-cell lymphocytosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Normocytic anaemia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Pancytopenia	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Polycythaemia	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Splenic infarction	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Splenomegaly	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Thrombocytopenia	0.22% 5/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Blood and lymphatic system disorders Thrombocytopenic purpura	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Acute coronary syndrome	0.27% 6/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.24% 14/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Acute left ventricular failure	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Acute myocardial infarction	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.21% 7/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.2% 71/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Adams-Stokes syndrome	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Angina pectoris	1.9% 42/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.8% 41/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.7% 37/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	2.3% 76/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.1% 66/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Angina unstable	1.7% 39/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.5% 34/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.7% 37/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.9% 63/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.97% 56/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Aortic valve incompetence	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Aortic valve stenosis	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Arrhythmia	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 3/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Arteriospasm coronary	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Atrial fibrillation	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.26% 6/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.85% 49/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Atrial flutter	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.10% 6/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Atrial tachycardia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Atrial thrombosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Atrioventricular block	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Atrioventricular block complete	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.07% 4/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Atrioventricular block first degree	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Atrioventricular block second degree	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 2/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Bradyarrhythmia	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Bradycardia	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.30% 10/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.10% 6/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Cardiac aneurysm	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Cardiac arrest	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.31% 7/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.32% 7/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.45% 15/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.16% 9/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Cardiac discomfort	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Cardiac failure	0.22% 5/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.18% 4/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.32% 7/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.74% 43/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Cardiac failure acute	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.28% 16/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Cardiac failure chronic	0.22% 5/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.26% 15/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Cardiac failure congestive	0.18% 4/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.52% 30/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Cardiac fibrillation	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Cardiac pseudoaneurysm	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Cardiac tamponade	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Cardiac ventricular thrombosis	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Cardio-respiratory arrest	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.10% 6/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Cardiogenic shock	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.13% 3/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.14% 3/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.21% 7/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.16% 9/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Cardiomegaly	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Cardiomyopathy	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Cardiopulmonary failure	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Conduction disorder	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Congestive cardiomyopathy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Cor pulmonale	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Coronary artery disease	0.40% 9/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.44% 10/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.23% 5/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.60% 20/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.47% 27/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Coronary artery insufficiency	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.02% 1/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Coronary artery occlusion	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Coronary artery stenosis	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.06% 2/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.24% 14/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Hypertensive heart disease	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Intracardiac thrombus	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Ischaemic cardiomyopathy	0.13% 3/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.22% 5/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.09% 2/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.12% 4/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.10% 6/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Left ventricular dysfunction	0.09% 2/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.03% 1/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 3/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Left ventricular failure	0.04% 1/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Cardiac disorders Left ventricular hypertrophy	0.00% 0/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.04% 1/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.05% 1/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.00% 0/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.

Other adverse events

Measure	Group I n=2263 participants at risk Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group II n=2285 participants at risk Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group III n=2170 participants at risk Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group IV n=3348 participants at risk Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	Group V n=5777 participants at risk Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy.
Cardiac disorders Angina pectoris	6.3% 142/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	7.2% 164/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	5.9% 129/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	6.8% 228/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	2.0% 115/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Gastrointestinal disorders Diarrhoea	6.1% 138/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	6.4% 146/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	6.3% 137/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	6.5% 216/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.9% 110/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Fatigue	5.0% 113/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	4.3% 99/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	3.9% 84/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	5.0% 169/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.2% 72/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Non-cardiac chest pain	6.3% 142/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	6.3% 143/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	5.1% 111/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	6.8% 228/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.2% 68/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
General disorders Oedema peripheral	6.0% 136/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	6.2% 142/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	6.2% 134/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	5.2% 173/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.9% 110/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Bronchitis	5.8% 131/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	7.1% 162/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	5.3% 114/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	7.0% 234/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	2.8% 160/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Influenza	6.2% 141/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	6.3% 145/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	5.4% 118/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	5.8% 194/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	2.7% 154/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Upper respiratory tract infection	6.8% 153/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	6.8% 156/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	6.2% 134/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	7.5% 252/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	2.2% 125/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Urinary tract infection	5.6% 126/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	5.6% 129/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	4.3% 93/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	5.2% 175/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	2.1% 123/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Infections and infestations Viral upper respiratory tract infection	11.7% 264/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	13.0% 297/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	12.1% 263/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	11.6% 388/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	0.28% 16/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Arthralgia	7.3% 165/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	7.9% 181/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	6.6% 144/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	7.5% 252/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	3.2% 184/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Back pain	7.5% 169/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	7.7% 177/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	7.2% 157/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	8.3% 277/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	2.8% 163/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Musculoskeletal and connective tissue disorders Pain in extremity	6.4% 145/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	6.3% 145/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	4.5% 98/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	6.1% 204/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	2.2% 128/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Dizziness	5.0% 114/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	5.5% 126/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	6.1% 132/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	5.6% 189/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.9% 107/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Nervous system disorders Headache	5.9% 133/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	4.9% 111/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	5.5% 120/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	5.3% 178/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.2% 72/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Cough	6.7% 151/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	6.7% 152/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	5.6% 121/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	7.0% 233/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.8% 103/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.6% 126/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	5.4% 123/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	5.1% 110/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	5.8% 193/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	1.9% 112/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.
Vascular disorders Hypertension	8.7% 198/2263 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	9.5% 216/2285 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	9.6% 208/2170 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	9.2% 309/3348 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.	4.2% 241/5777 • Core phase: From randomization to end of treatment plus 30 days; up to approximately 6 years; Extension phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years. AEs/SAEs are any signs or symptoms that occur during the study treatment. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: Novartis.email@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER