Trial Outcomes & Findings for A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer (NCT NCT01212991)

NCT ID: NCT01212991

Last Updated: 2020-03-17

Results Overview

Overall survival was defined as the time from randomization to death due to any cause. For patients who were alive at the time of the analysis data cutoff, overall survival was censored at the last date the patient was known to be alive or analysis data cutoff date, whichever was first. This included patients who were known to have died after the data analysis cutoff date. Patients with no post-baseline survival information were censored on the date of randomization.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1717 participants
• Primary outcome timeframe: During study period (up to 3 years)
• Results posted on: 2020-03-17

Participant Flow

Following the independent data monitoring committee's recommendation, a protocol amendment was implemented for double-blind phase to be proceeded to open-label phase, which allowed previously placebo treated participants who had not received commercial enzalutamide the opportunity, to receive open-label access to enzalutamide.

Participant milestones

Measure	Enzalutamide Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.	Placebo Participants received placebo, administered as four capsules, once per day by mouth.	Placebo Participants Crossover to Enzalutamide Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
Double-blind STARTED	872	845	0
Double-blind Safety Population	871	844	0
Double-blind COMPLETED	0	234	0
Double-blind NOT COMPLETED	872	611	0
Open-label STARTED	0	0	234
Open-label COMPLETED	0	0	0
Open-label NOT COMPLETED	0	0	234

Reasons for withdrawal

Measure	Enzalutamide Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.	Placebo Participants received placebo, administered as four capsules, once per day by mouth.	Placebo Participants Crossover to Enzalutamide Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
Double-blind Lost to Follow-up	8	4	0
Double-blind Death	699	550	0
Double-blind Withdrawal by Subject	16	19	0
Double-blind Other	7	0	0
Double-blind Sponsor decision	142	38	0
Open-label Death	0	0	166
Open-label Lost to Follow-up	0	0	5
Open-label Withdrawal by Subject	0	0	7
Open-label Sponsor decision	0	0	53
Open-label Other	0	0	3

Baseline Characteristics

A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer

Baseline characteristics by cohort

Measure	Enzalutamide n=872 Participants Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.	Placebo n=845 Participants Participants received placebo, administered as four capsules, once per day by mouth.	Total n=1717 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	179 Participants n=5 Participants	179 Participants n=7 Participants	358 Participants n=5 Participants
Age, Categorical >=65 years	693 Participants n=5 Participants	666 Participants n=7 Participants	1359 Participants n=5 Participants
Age, Continuous	71.3 years STANDARD_DEVIATION 8.51 • n=5 Participants	71.2 years STANDARD_DEVIATION 8.42 • n=7 Participants	71.3 years STANDARD_DEVIATION 8.47 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	872 Participants n=5 Participants	845 Participants n=7 Participants	1717 Participants n=5 Participants
Region of Enrollment United States	127 count of participants n=5 Participants	120 count of participants n=7 Participants	247 count of participants n=5 Participants
Region of Enrollment Slovakia	13 count of participants n=5 Participants	14 count of participants n=7 Participants	27 count of participants n=5 Participants
Region of Enrollment Finland	18 count of participants n=5 Participants	15 count of participants n=7 Participants	33 count of participants n=5 Participants
Region of Enrollment Spain	44 count of participants n=5 Participants	37 count of participants n=7 Participants	81 count of participants n=5 Participants
Region of Enrollment Lithuania	8 count of participants n=5 Participants	6 count of participants n=7 Participants	14 count of participants n=5 Participants
Region of Enrollment Austria	9 count of participants n=5 Participants	9 count of participants n=7 Participants	18 count of participants n=5 Participants
Region of Enrollment Russian Federation	12 count of participants n=5 Participants	10 count of participants n=7 Participants	22 count of participants n=5 Participants
Region of Enrollment Israel	14 count of participants n=5 Participants	11 count of participants n=7 Participants	25 count of participants n=5 Participants
Region of Enrollment United Kingdom	78 count of participants n=5 Participants	75 count of participants n=7 Participants	153 count of participants n=5 Participants
Region of Enrollment Italy	15 count of participants n=5 Participants	15 count of participants n=7 Participants	30 count of participants n=5 Participants
Region of Enrollment France	85 count of participants n=5 Participants	90 count of participants n=7 Participants	175 count of participants n=5 Participants
Region of Enrollment Canada	91 count of participants n=5 Participants	88 count of participants n=7 Participants	179 count of participants n=5 Participants
Region of Enrollment Poland	21 count of participants n=5 Participants	18 count of participants n=7 Participants	39 count of participants n=5 Participants
Region of Enrollment Belgium	28 count of participants n=5 Participants	29 count of participants n=7 Participants	57 count of participants n=5 Participants
Region of Enrollment Singapore	5 count of participants n=5 Participants	4 count of participants n=7 Participants	9 count of participants n=5 Participants
Region of Enrollment Australia	116 count of participants n=5 Participants	116 count of participants n=7 Participants	232 count of participants n=5 Participants
Region of Enrollment Denmark	43 count of participants n=5 Participants	44 count of participants n=7 Participants	87 count of participants n=5 Participants
Region of Enrollment Netherlands	15 count of participants n=5 Participants	13 count of participants n=7 Participants	28 count of participants n=5 Participants
Region of Enrollment Germany	41 count of participants n=5 Participants	42 count of participants n=7 Participants	83 count of participants n=5 Participants
Region of Enrollment Japan	28 count of participants n=5 Participants	33 count of participants n=7 Participants	61 count of participants n=5 Participants
Region of Enrollment Sweden	21 count of participants n=5 Participants	18 count of participants n=7 Participants	39 count of participants n=5 Participants
Region of Enrollment Korea, Republic of	40 count of participants n=5 Participants	38 count of participants n=7 Participants	78 count of participants n=5 Participants

PRIMARY outcome

Timeframe: During study period (up to 3 years)

Population: Intent to Treat (ITT) - All patients randomly assigned to treatment.

Overall survival was defined as the time from randomization to death due to any cause. For patients who were alive at the time of the analysis data cutoff, overall survival was censored at the last date the patient was known to be alive or analysis data cutoff date, whichever was first. This included patients who were known to have died after the data analysis cutoff date. Patients with no post-baseline survival information were censored on the date of randomization.

Outcome measures

Measure	Enzalutamide n=872 Participants Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.	Placebo n=845 Participants Participants received placebo, administered as four capsules, once per day by mouth.	Placebo Participants Crossover to Enzalutamide Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
Overall Survival	32.4 months Interval 30.1 to The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.	30.2 months Interval 28.0 to The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.	—

PRIMARY outcome

Timeframe: During study period (up to 20 months)

Population: Intent to Treat (ITT) - All patients randomly assigned to treatment excluding 84 patients who were not randomized before the radiographic Progression-free Survival data cutoff date of 06 May 2012.

Radiographic progression-free survival was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause within 168 days after treatment discontinuation, whichever was first. Radiographic disease progression was evaluated by CT scan or MRI and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using RECIST 1.1 for soft tissue disease and PCWG2 guidelines for bone disease. Patients who did not reach the endpoint were censored at their last assessment.

Outcome measures

Measure	Enzalutamide n=832 Participants Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.	Placebo n=801 Participants Participants received placebo, administered as four capsules, once per day by mouth.	Placebo Participants Crossover to Enzalutamide Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
Radiographic Progression-free Survival (rPFS)	NA months Interval 13.8 to The median time to radiographic progression-free survival and its upper 95% confidence limit were not yet reached in the enzalutamide group because an insufficient number of patients had an event at the time of analysis.	3.9 months Interval 3.7 to 5.4	—

SECONDARY outcome

Timeframe: During study period (up to 3 years)

Population: Intent to Treat (ITT) - All patients randomly assigned to treatment.

Time to first skeletal-related event was defined as the time from randomization to the date of the first occurrence of a skeletal-related event for each patient. A skeletal-related event was defined as radiation therapy or surgery to bone for prostate cancer, pathological bone fracture, spinal cord compression, or initiation/change in antineoplastic therapy to treat bone pain from prostate cancer. Skeletal-related events were recorded at each scheduled and unscheduled study visit and during long-term follow-up if a skeletal-related event was not documented previously. Patients who did not have a skeletal-related event at the time of the analysis data cutoff were censored at the date of last assessment indicating no evidence of skeletal-related event. Patients with no postbaseline assessments were censored on the date of randomization.

Outcome measures

Measure	Enzalutamide n=872 Participants Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.	Placebo n=845 Participants Participants received placebo, administered as four capsules, once per day by mouth.	Placebo Participants Crossover to Enzalutamide Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
Time to First Skeletal-related Event	31.1 months Interval 29.5 to The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.	31.3 months Interval 23.9 to The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.	—

SECONDARY outcome

Timeframe: During study period (up to 3 years)

Population: Intent to Treat (ITT) - All patients randomly assigned to treatment.

The time to initiation of cytotoxic chemotherapy is defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for the treatment of prostate cancer for each patient. For patients who did not start cytotoxic chemotherapy at the time of the analysis data cutoff, time to initiation of cytotoxic chemotherapy was censored at the date of last assessment where no cytotoxic chemotherapy was indicated or at the analysis data cutoff date, whichever was first. Time to initiation of cytotoxic chemotherapy for patients with no postbaseline assessments was censored on the date of randomization.

Outcome measures

Measure	Enzalutamide n=872 Participants Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.	Placebo n=845 Participants Participants received placebo, administered as four capsules, once per day by mouth.	Placebo Participants Crossover to Enzalutamide Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
Time to Initiation of Cytotoxic Chemotherapy	28.0 months Interval 25.8 to The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.	10.8 months Interval 9.7 to 12.2	—

SECONDARY outcome

Timeframe: During study period (up to 3 years)

Population: Intent to Treat (ITT) - All patients randomized.

Time to PSA progression was defined as the time from randomization to date of first confirmed observation of PSA progression for each patient. For patients with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir was documented, and confirmed 3 or more weeks later. For patients with no PSA decline at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above baseline was documented, and confirmed 3 or more weeks later. For patients who did not have confirmed PSA progression at the time of the analysis data cutoff, time to PSA progression was censored at the date of the last PSA assessment showing no evidence of confirmed PSA progression or the analysis data cutoff date, whichever was first. Time to PSA progression for patients with no postbaseline assessments was censored on the date of randomization.

Outcome measures

Measure	Enzalutamide n=872 Participants Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.	Placebo n=845 Participants Participants received placebo, administered as four capsules, once per day by mouth.	Placebo Participants Crossover to Enzalutamide Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
Time to Prostate-specific Antigen (PSA) Progression	11.2 months Interval 11.1 to 13.7	2.8 months Interval 2.8 to 2.9	—

SECONDARY outcome

Timeframe: During study period (up to 3 years)

Population: Evaluable intent to treat (ITT) population - All patients randomly assigned to treatment with PSA values at baseline and at least one postbaseline assessment.

PSA response was defined as a ≥ 50% reduction in PSA from baseline to the lowest postbaseline PSA value and required confirmation by a consecutive assessment at least 3 weeks later. Patients were evaluable for PSA response rate if a patient had a PSA level measured at baseline and at least one postbaseline assessment.

Outcome measures

Measure	Enzalutamide n=854 Participants Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.	Placebo n=777 Participants Participants received placebo, administered as four capsules, once per day by mouth.	Placebo Participants Crossover to Enzalutamide Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
Percentage of Patients With Prostate Specific Antigen (PSA) Response ≥ 50%	78 Percentage of Participants Interval 75.1 to 80.7	3.5 Percentage of Participants Interval 2.3 to 5.0	—

SECONDARY outcome

Timeframe: During study period (up to 3 years)

Population: Intent to treat (ITT) population With Measurable Disease - All participants who were randomly assigned to treatment and had at least one target lesion at screening.

The best overall soft tissue objective response is defined as partial response [PR] or complete response [CR] while on study treatment based on investigator assessments of target, nontarget, and new lesions using RECIST 1.1. Soft tissue was assessed by CT or MRI at regularly scheduled visits. Only patients with measurable soft tissue disease (ie, at least 1 target lesion identified per RECIST 1.1) at screening are included in this analysis. All percentages are based on number of participants with measurable soft tissue disease at screening in each treatment group.

Outcome measures

Measure	Enzalutamide n=396 Participants Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.	Placebo n=381 Participants Participants received placebo, administered as four capsules, once per day by mouth.	Placebo Participants Crossover to Enzalutamide Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
Best Overall Soft Tissue Response	58.8 Percentage of participants	5.0 Percentage of participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)

Population: The safety analysis set included all randomized participants who received at least 1 dose or partial dose of study drug.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to a maximum of 6.5 years that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.

Outcome measures

Measure	Enzalutamide n=871 Participants Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.	Placebo n=844 Participants Participants received placebo, administered as four capsules, once per day by mouth.	Placebo Participants Crossover to Enzalutamide n=234 Participants Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	857 Participants	791 Participants	212 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	384 Participants	229 Participants	104 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)

Population: The safety analysis set included all randomized participants who received at least 1 dose or partial dose of study drug.

An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. As per NCI CTCAE, Grade 3 events =medically significant but not immediately life-threatening, unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment, Grade 4 events =participant to be in imminent danger of death. Grade 5 events =death. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug up to a maximum duration of 6.5 years. Number of participants with AEs of any of the Grade 3 or above (Grade 4, 5) were reported.

Outcome measures

Measure	Enzalutamide n=871 Participants Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.	Placebo n=844 Participants Participants received placebo, administered as four capsules, once per day by mouth.	Placebo Participants Crossover to Enzalutamide n=234 Participants Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
Number of Participants With Treatment-Emergent Adverse Events (AEs) Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute Common Terminology Criteria for AEs (CTCAE), Version 4.0	465 Participants	318 Participants	129 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)

Population: The safety analysis set included all randomized participants who received at least 1 dose or partial dose of study drug.

Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to a maximum duration of 6.5 years that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.

Outcome measures

Measure	Enzalutamide n=871 Participants Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.	Placebo n=844 Participants Participants received placebo, administered as four capsules, once per day by mouth.	Placebo Participants Crossover to Enzalutamide n=234 Participants Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	579 Participants	423 Participants	119 Participants
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	38 Participants	22 Participants	14 Participants

Adverse Events

Enzalutamide

Serious events: 384 serious events

Other events: 814 other events

Deaths: 699 deaths

Placebo

Serious events: 229 serious events

Other events: 723 other events

Deaths: 550 deaths

Placebo Participants Crossover to Enzalutamide

Serious events: 104 serious events

Other events: 180 other events

Deaths: 166 deaths

Serious adverse events

Measure	Enzalutamide n=871 participants at risk Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.	Placebo n=844 participants at risk Participants received placebo, administered as four capsules, once per day by mouth.	Placebo Participants Crossover to Enzalutamide n=234 participants at risk Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
Blood and lymphatic system disorders Anaemia	2.1% 18/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	1.1% 9/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	2.6% 6/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Blood and lymphatic system disorders Iron deficiency anaemia	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Blood and lymphatic system disorders Neutropenia	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Blood and lymphatic system disorders Pancytopenia	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Atrial fibrillation	1.1% 10/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.71% 6/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Acute myocardial infarction	1.3% 11/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Arteriosclerosis coronary artery	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Atrioventricular block	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Acute coronary syndrome	0.57% 5/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Angina pectoris	0.34% 3/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Angina unstable	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Cardiac failure acute	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Congestive cardiomyopathy	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Hypertensive heart disease	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Sick sinus syndrome	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Sinus tachycardia	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Ventricular tachycardia	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Ventricular extrasystoles	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Ear and labyrinth disorders Vertigo	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Endocrine disorders Adrenal insufficiency	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Endocrine disorders Goitre	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Eye disorders Amaurosis	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Eye disorders Cataract	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Eye disorders Retinal artery occlusion	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Constipation	0.57% 5/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.59% 5/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.85% 2/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Vomiting	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.24% 2/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Diarrhoea	0.34% 3/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Nausea	0.34% 3/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.85% 2/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.46% 4/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Abdominal pain	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Inguinal hernia	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.24% 2/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Melaena	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Small intestinal obstruction	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Abdominal pain lower	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Dysphagia	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Large intestinal haemorrhage	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Large intestine polyp	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Pancreatitis acute	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Peritoneal haemorrhage	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Rectal stenosis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Subileus	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Duodenal ulcer	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Gastritis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders General physical health deterioration	1.7% 15/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	1.2% 10/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	2.6% 6/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Disease progression	1.1% 10/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.83% 7/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	4.7% 11/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Death	0.57% 5/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Oedema peripheral	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.36% 3/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Fatigue	0.57% 5/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.85% 2/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Gait disturbance	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Pain	0.34% 3/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Performance status decreased	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.24% 2/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Pyrexia	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	1.3% 3/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Asthenia	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	2.1% 5/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Chest pain	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Device dislocation	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Drowning	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Generalized oedema	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Medical device complication	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Non-cardiac chest pain	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Oedema	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Sudden death	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Suprapubic pain	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Adverse drug reaction	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Device occlusion	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Local swelling	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Hepatobiliary disorders Cholecystitis	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Hepatobiliary disorders Hepatic failure	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Hepatobiliary disorders Hepatic function abnormal	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Hepatobiliary disorders Jaundice	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Hepatobiliary disorders Jaundice cholestatic	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Immune system disorders Anaphylactic shock	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Immune system disorders Drug hypersensitivity	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Pneumonia	1.6% 14/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.83% 7/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	3.4% 8/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Urinary tract infection	0.92% 8/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.59% 5/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	4.3% 10/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Urosepsis	0.57% 5/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.36% 3/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	1.7% 4/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Sepsis	0.34% 3/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.47% 4/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Gastroenteritis	0.46% 4/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Device related infection	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Bronchitis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Cellulitis	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Herpes zoster	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Appendicitis	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Appendicitis perforated	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Bacteraemia	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Diverticulitis	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Gallbladder abscess	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Gastroenteritis staphylococcal	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Femoral neck fracture	0.80% 7/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Lower respiratory tract infection	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Osteomyelitis	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Peritonitis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Respiratory tract infection	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Septic shock	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Urinary tract infection fungal	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Viral infection	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Wound infection	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Chronic sinusitis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Fall	1.4% 12/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.36% 3/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.85% 2/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Femur fracture	0.34% 3/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.24% 2/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Spinal compression fracture	0.46% 4/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Road traffic accident	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Humerus fracture	0.46% 4/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Wrist fracture	0.34% 3/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Hip fracture	0.34% 3/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.24% 2/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.24% 2/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.85% 2/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Toxicity to various agents	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Cystitis radiation	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Ankle fracture	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Chest injury	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Clavicle fracture	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Extradural haematoma	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Facial bones fracture	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Foreign body	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Gastroenteritis radiation	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Head injury	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Radiation oesophagitis	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Radius fracture	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Skeletal injury	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Subdural haemorrhage	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Traumatic fracture	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Upper limb fracture	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Contrast media reaction	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Contusion	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Lower limb fracture	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Post procedural haematuria	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Procedural pain	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Pubis fracture	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Investigations Electrocardiogram QT prolonged	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Investigations Haemoglobin decreased	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Investigations Platelet count decreased	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Investigations Hepatic enzyme increased	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.24% 2/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Investigations Arteriogram coronary	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Investigations Blood creatinine increased	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Investigations Coagulation time prolonged	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Investigations Eastern cooperative oncology group performance status worsened	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Investigations International normalized ratio increased	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Investigations Electrocardiogram repolarisation abnormality	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Investigations Weight decreased	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Metabolism and nutrition disorders Dehydration	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.36% 3/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Metabolism and nutrition disorders Decreased appetite	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.24% 2/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Metabolism and nutrition disorders Hypercalcaemia	0.34% 3/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Metabolism and nutrition disorders Hypoglycaemia	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Metabolism and nutrition disorders Cachexia	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Metabolism and nutrition disorders Fluid retention	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Metabolism and nutrition disorders Hyperkalaemia	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Metabolism and nutrition disorders Hypokalaemia	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Metabolism and nutrition disorders Metabolic acidosis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Pathological Fracture	1.7% 15/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.71% 6/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	1.3% 3/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Back pain	0.46% 4/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.59% 5/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Bone pain	0.34% 3/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.59% 5/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.92% 8/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.24% 2/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.85% 2/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.46% 4/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Muscular weakness	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.24% 2/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.36% 3/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Arthralgia	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.24% 2/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Osteolysis	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.24% 2/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Myalgia	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Periostitis	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Arthritis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Groin pain	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Pain in extremity	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic pain	2.1% 18/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	2.0% 17/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	1.7% 4/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.34% 3/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.36% 3/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.85% 2/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.46% 4/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.85% 2/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Status Epilepticus	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.24% 2/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to soft tissue	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.24% 2/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.34% 3/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal adenocarcinoma	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bladder	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone marrow	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to breast	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.85% 2/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteosarcoma	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer limited stage	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid adenoma	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour embolism	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.34% 3/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Spinal cord compression	4.0% 35/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	3.0% 25/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	4.3% 10/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Syncope	0.92% 8/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	1.3% 3/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Cerebrovascular accident	0.80% 7/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Cauda equina syndrome	0.46% 4/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Nerve root compression	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.24% 2/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Transient ischaemic attack	0.69% 6/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.36% 3/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Presyncope	0.34% 3/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Paraesthesia	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.24% 2/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Paraparesis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Ataxia	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Brain injury	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Cerebral haemorrhage	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Cerebral infarction	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Cervicobrachial syndrome	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Coma hepatic	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Dementia	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Memory impairment	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Meningorrhagia	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Metabolic encephalopathy	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Reversible ischaemic neurological deficit	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Spinal cord ischaemia	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Subarachnoid haemorrhage	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Vith nerve disorder	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Complex partial seizures	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Neuralgia	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Sciatica	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.24% 2/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Psychiatric disorders Confusional state	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.47% 4/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.85% 2/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Psychiatric disorders Suicide attempt	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Psychiatric disorders Depression	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Psychiatric disorders Major depression	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Urinary retention	1.1% 10/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	1.5% 13/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	1.3% 3/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Haematuria	1.3% 11/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	1.4% 12/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	1.3% 3/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Urinary tract obstruction	0.92% 8/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	1.1% 9/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Hydronephrosis	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	1.3% 11/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Renal failure acute	0.69% 6/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.59% 5/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.85% 2/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Ureteric obstruction	0.46% 4/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.47% 4/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Obstructive uropathy	0.57% 5/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.71% 6/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	1.3% 3/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Bladder outlet obstruction	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.36% 3/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Postrenal failure	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.36% 3/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Urinary bladder haemorrhage	0.34% 3/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Calculus bladder	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Prerenal failure	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Renal failure	0.34% 3/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Acute prerenal failure	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Bladder obstruction	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Renal failure chronic	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Urethral meatus stenosis	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Urethral obstruction	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Urine flow decreased	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Bladder neck obstruction	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Micturition urgency	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Reproductive system and breast disorders Pelvic pain	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Reproductive system and breast disorders Prostatic obstruction	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Reproductive system and breast disorders Prostatitis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Reproductive system and breast disorders Testicular pain	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.69% 6/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.83% 7/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.57% 5/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.36% 3/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.34% 3/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.24% 2/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Aspiration	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.34% 3/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Restrictive pulmonary disease	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Tracheal obstruction extrinsic	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Skin and subcutaneous tissue disorders Rash	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Skin and subcutaneous tissue disorders Swelling face	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Surgical and medical procedures Cancer hormonal therapy	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Surgical and medical procedures Pain management	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Vascular disorders Deep vein thrombosis	0.46% 4/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.24% 2/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Vascular disorders Hypertension	0.46% 4/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Vascular disorders Hypotension	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Vascular disorders Orthostatic hypotension	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Vascular disorders Aortic aneurysm	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Vascular disorders Aortic aneurysm rupture	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Vascular disorders Circulatory collapse	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Vascular disorders Hypovolaemic shock	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Vascular disorders Lymphoedema	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Vascular disorders Vena cava thrombosis	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Vascular disorders Aortic stenosis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Vascular disorders Phlebitis	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Vascular disorders Subclavian artery stenosis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Blood and lymphatic system disorders Haemolytic Uraemic Syndrome	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Blood and lymphatic system disorders Idiopathic Thrombocytopenic Purpura	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Blood and lymphatic system disorders Lymphadenopathy	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Blood and lymphatic system disorders Platelet Dysfunction	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Atrial Flutter	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.85% 2/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Atrial Tachycardia	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Atrioventricular Block Complete	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Bradycardia	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Cardiac Arrest	0.34% 3/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.24% 2/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Cardiac Failure	0.57% 5/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.24% 2/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	1.3% 3/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Cardiac Failure Congestive	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Cardiopulmonary Failure	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Cardiovascular Insufficiency	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Coronary Artery Disease	0.69% 6/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Coronary Artery Stenosis	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Ischaemic Cardiomyopathy	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Left Ventricular Failure	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Mitral Valve Disease	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Mitral Valve Incompetence	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Myocardial Infarction	0.69% 6/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Supraventricular Tachycardia	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Tricuspid Valve Incompetence	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Ventricular Fibrillation	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Cardiac disorders Wolff-Parkinson-White Syndrome	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Eye disorders Eyelid Ptosis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Eye disorders Retinal Vein Occlusion	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Anal Stenosis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Gastrointestinal Ulcer	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Ileus	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Oesophageal Spasm	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Peptic Ulcer	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.85% 2/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Device Malfunction	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Medical Device Pain	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Multi-Organ Failure	0.34% 3/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Hepatobiliary disorders Bile Duct Stone	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Hepatobiliary disorders Cholangitis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Hepatobiliary disorders Hepatic Cyst	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Acute Sinusitis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Arthritis Bacterial	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Cholecystitis Infective	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Clostridium Difficile Colitis	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Clostridium Difficile Sepsis	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Erysipelas	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Escherichia Urinary Tract Infection	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Infected Dermal Cyst	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Infection	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	1.3% 3/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Meningitis Pneumococcal	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Postoperative Wound Infection	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Pulmonary Sepsis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Pyelonephritis Acute	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.85% 2/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Back Injury	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Cervical Vertebral Fracture	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Joint Injury	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Post Procedural Bile Leak	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Renal Haematoma	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Rib Fracture	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Spinal Fracture	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Sternal Fracture	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Thoracic Vertebral Fracture	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Investigations Biopsy	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Investigations Ejection Fraction Decreased	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Investigations Electrocardiogram Abnormal	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Metabolism and nutrition disorders Hypophagia	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Metabolism and nutrition disorders Malnutrition	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Bursitis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Cervical Spinal Stenosis	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Synovial Cyst	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Myeloid Leukaemia	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Neoplasm	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Adenocarcinoma	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Cancer Metastatic	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse Large B-Cell Lymphoma	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer Recurrent	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal Cancer Metastatic	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma Multiforme	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Chest Wall	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Penis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Neoplasm	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myxofibrosarcoma	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's Lymphoma	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma Cell Myeloma	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Cell Lung Cancer	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma Of Skin	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Cervical Cord Compression	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Convulsion	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Cranial Nerve Paralysis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Grand Mal Convulsion	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Haemorrhage Intracranial	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Headache	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Hypoxic-Ischaemic Encephalopathy	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Lethargy	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Loss Of Consciousness	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Neurological Symptom	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Sensory Loss	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Vith Nerve Paralysis	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Dizziness	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Epiduritis	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Monoplegia	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Psychiatric disorders Delirium	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Calculus Ureteric	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Nephrolithiasis	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Renal Colic	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Urethral Stenosis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Urinary Incontinence	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Reproductive system and breast disorders Epididymitis	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.12% 1/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Surgical and medical procedures Knee Arthroplasty	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Surgical and medical procedures Radical Cystectomy	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Surgical and medical procedures Umbilical Hernia Repair	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Vascular disorders Aneurysm	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Vascular disorders Peripheral Artery Stenosis	0.11% 1/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Nephrotic Syndrome	0.00% 0/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.43% 1/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Calculus Urinary	0.23% 2/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.00% 0/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.

Other adverse events

Measure	Enzalutamide n=871 participants at risk Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.	Placebo n=844 participants at risk Participants received placebo, administered as four capsules, once per day by mouth.	Placebo Participants Crossover to Enzalutamide n=234 participants at risk Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
Infections and infestations Urinary tract infection	8.0% 70/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	6.6% 56/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	4.7% 11/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Blood and lymphatic system disorders Anaemia	8.7% 76/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	8.1% 68/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	9.8% 23/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Nausea	24.2% 211/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	22.7% 192/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	14.5% 34/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Constipation	25.3% 220/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	17.2% 145/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	16.2% 38/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Diarrhoea	18.4% 160/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	14.3% 121/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	8.5% 20/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Vomiting	7.3% 64/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	8.3% 70/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	3.8% 9/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Gastrointestinal disorders Abdominal pain	6.4% 56/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	3.7% 31/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	1.7% 4/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Fatigue	38.1% 332/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	26.1% 220/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	26.9% 63/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Asthenia	14.0% 122/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	8.2% 69/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	6.4% 15/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
General disorders Oedema peripheral	13.2% 115/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	8.3% 70/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	8.5% 20/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Nasopharyngitis	8.5% 74/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	5.2% 44/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	2.6% 6/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Infections and infestations Upper respiratory tract infection	7.0% 61/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	3.6% 30/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	3.0% 7/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Injury, poisoning and procedural complications Fall	15.6% 136/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	5.0% 42/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	6.4% 15/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Investigations Weight decreased	14.0% 122/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	8.5% 72/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	11.1% 26/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Metabolism and nutrition disorders Decreased appetite	20.9% 182/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	16.5% 139/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	15.4% 36/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Back pain	32.1% 280/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	22.3% 188/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	13.7% 32/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Arthralgia	23.7% 206/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	16.2% 137/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	9.4% 22/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Pain in extremity	14.2% 124/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	11.5% 97/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	5.6% 13/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Bone pain	11.5% 100/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	13.7% 116/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	7.7% 18/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	12.9% 112/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	8.8% 74/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	12.0% 28/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	8.4% 73/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	4.7% 40/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	2.1% 5/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Myalgia	6.8% 59/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	5.8% 49/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	3.4% 8/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Headache	11.7% 102/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	7.0% 59/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	6.4% 15/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Dizziness	9.8% 85/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	6.4% 54/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	5.6% 13/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Nervous system disorders Dysgeusia	7.7% 67/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	3.7% 31/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	2.1% 5/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Psychiatric disorders Insomnia	9.0% 78/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	5.7% 48/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	4.3% 10/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Haematuria	10.7% 93/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	5.1% 43/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	4.7% 11/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Renal and urinary disorders Pollakiuria	7.1% 62/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	4.4% 37/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	2.6% 6/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Cough	10.9% 95/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	6.9% 58/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	0.85% 2/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.1% 88/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	7.1% 60/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	6.0% 14/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Vascular disorders Hot flush	18.3% 159/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	7.8% 66/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	4.7% 11/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Vascular disorders Hypertension	17.0% 148/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	4.3% 36/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	12.0% 28/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Musculoskeletal and connective tissue disorders Muscular Weakness	5.2% 45/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	3.2% 27/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	3.4% 8/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
Skin and subcutaneous tissue disorders Rash	3.6% 31/871 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	2.5% 21/844 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.	6.0% 14/234 • Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee PI agrees not to independently publish the results before the publication of the multi-center PI paper. Sponsor shall review and comment 30 days prior to submission or disclosure. If publication or disclosure contains Sponsor Confidential Information, other than study data, PI agrees to remove Confidential Information from publication or disclosure. Sponsor may request that PI delay such publication for an additional 60 days to protect the patentability of any invention described.
• Publication restrictions are in place

Restriction type: OTHER