Trial Outcomes & Findings for Transthyretin Amyloidosis Outcome Survey (THAOS) (NCT NCT00628745)

NCT ID: NCT00628745

Last Updated: 2024-11-22

Results Overview

An AE was any untoward medical occurrence in a participant who administered a medicinal product without regard to possibility of causal relationship with the study treatment. SAE was defined as one of the following: resulted in death; was life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); constituted a congenital anomaly/birth defect. Treatment-emergent AE was defined as an AE with onset date occurring during the on-treatment period. AEs included all SAEs and non-SAEs.

• Recruitment status: COMPLETED
• Target enrollment: 6718 participants
• Primary outcome timeframe: From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years)
• Results posted on: 2024-11-22

Participant Flow

THAOS (Transthyretin Amyloidosis Outcome Survey) was a non-interventional, longitudinal observational survey opened to all participants with ATTR (Transthyretin Amyloidosis), including both inherited and wild-type forms of disease and those with TTR gene mutations without disease diagnosis. There was no planned enroll number. THAOS did not involve the administration of an intervention. Participants continued to receive their previous medications and all other standard care for their disease.

Participant milestones

Measure	Tafamidis 20 mg Treated All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.	Tafamidis Untreated All available data from participants who had been enrolled in THAOS, signed the informed consent and who had not received tafamidis during the THAOS study.
Overall Study STARTED	1648	662	196	15	4197
Overall Study COMPLETED	4	0	1	0	8
Overall Study NOT COMPLETED	1644	662	195	15	4189

Reasons for withdrawal

Measure	Tafamidis 20 mg Treated All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.	Tafamidis Untreated All available data from participants who had been enrolled in THAOS, signed the informed consent and who had not received tafamidis during the THAOS study.
Overall Study Withdrawal by Subject	63	3	9	2	69
Overall Study Does not meet inclusion criteria	0	12	0	0	18
Overall Study Participation in an interventional clinical trial	81	4	7	0	63
Overall Study Physician Decision	8	4	3	0	30
Overall Study Lost to Follow-up	109	7	7	0	498
Overall Study Death	197	81	12	4	939
Overall Study Participant transferred to another THAOS site	6	0	0	0	7
Overall Study Participant moved out of the area, but did not transfer to another THAOS site	37	29	46	0	91
Overall Study Site closure	152	146	6	8	691
Overall Study Duplicate participant	0	0	0	0	1
Overall Study Missing	4	3	0	0	10
Overall Study Othe reasons	987	373	105	1	1772

Baseline Characteristics

Transthyretin Amyloidosis Outcome Survey (THAOS)

Baseline characteristics by cohort

Measure	Tafamidis 20 mg Treated n=1648 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=662 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=196 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall n=15 Participants All available data from participants who received any other dose of Tafamidis throughout the study.	Tafamidis Untreated n=4197 Participants All available data from participants who had been enrolled in THAOS, signed the informed consent and who had not received tafamidis during the THAOS study.	Total n=6718 Participants Total of all reporting groups
Race/Ethnicity, Customized Black or African American	11 Participants n=5 Participants	53 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	225 Participants n=21 Participants	294 Participants n=10 Participants
Race/Ethnicity, Customized Caucasian	600 Participants n=5 Participants	512 Participants n=7 Participants	46 Participants n=5 Participants	12 Participants n=4 Participants	2271 Participants n=21 Participants	3441 Participants n=10 Participants
Age, Continuous	50.8 Years STANDARD_DEVIATION 17.75 • n=5 Participants	76.0 Years STANDARD_DEVIATION 8.65 • n=7 Participants	77.7 Years STANDARD_DEVIATION 10.66 • n=5 Participants	77.9 Years STANDARD_DEVIATION 11.33 • n=4 Participants	57.1 Years STANDARD_DEVIATION 19.08 • n=21 Participants	58.1 Years STANDARD_DEVIATION 19.31 • n=10 Participants
Sex: Female, Male Female	734 Participants n=5 Participants	62 Participants n=7 Participants	33 Participants n=5 Participants	4 Participants n=4 Participants	1581 Participants n=21 Participants	2414 Participants n=10 Participants
Sex: Female, Male Male	914 Participants n=5 Participants	600 Participants n=7 Participants	163 Participants n=5 Participants	11 Participants n=4 Participants	2616 Participants n=21 Participants	4304 Participants n=10 Participants
Race/Ethnicity, Customized Afro-Caribbean	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	22 Participants n=21 Participants	24 Participants n=10 Participants
Race/Ethnicity, Customized American Hispanic	8 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	16 Participants n=21 Participants	29 Participants n=10 Participants
Race/Ethnicity, Customized Asian	110 Participants n=5 Participants	12 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	170 Participants n=21 Participants	295 Participants n=10 Participants
Race/Ethnicity, Customized Latino American	42 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	138 Participants n=21 Participants	182 Participants n=10 Participants
Race/Ethnicity, Customized Other	18 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	113 Participants n=21 Participants	132 Participants n=10 Participants
Race/Ethnicity, Customized Missing	859 Participants n=5 Participants	77 Participants n=7 Participants	143 Participants n=5 Participants	0 Participants n=4 Participants	1242 Participants n=21 Participants	2321 Participants n=10 Participants

PRIMARY outcome

Timeframe: From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years)

Population: TEAEs and SAEs were summarised for only Tafamidis treated set: all available data from participants who have been enrolled in THAOS, signed the informed consent and were on tafamidis treatment on or prior to the date of enrollment of THAOS, or subsequently initiated tafamidis treatment after the enrollment of THAOS.

An AE was any untoward medical occurrence in a participant who administered a medicinal product without regard to possibility of causal relationship with the study treatment. SAE was defined as one of the following: resulted in death; was life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); constituted a congenital anomaly/birth defect. Treatment-emergent AE was defined as an AE with onset date occurring during the on-treatment period. AEs included all SAEs and non-SAEs.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=1648 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=662 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=196 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall n=15 Participants All available data from participants who received any other dose of Tafamidis throughout the study.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with Adverse Events	621 Participants	175 Participants	66 Participants	4 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with Serious Adverse Events	331 Participants	138 Participants	41 Participants	3 Participants

PRIMARY outcome

Timeframe: From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years)

Population: Treatment emergent treatment related AEs and SAEs were summarised for only tafamidis treated set: all available data from participants who have been enrolled in THAOS, signed the informed consent and were on tafamidis treatment on or prior to the date of enrollment of THAOS, or subsequently initiated tafamidis treatment after the enrollment of THAOS.

A treatment-related AE was any untoward medical occurrence attributed to the administered medicinal product in a participant who received study drug. Treatment emergent AEs included both SAEs and all non-SAEs. A treatment-related SAE was a treatment-related AE and was defined as any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); constituted a congenital anomaly/birth defect. Causality was assessed by the investigator.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=1648 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=662 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=196 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall n=15 Participants All available data from participants who received any other dose of Tafamidis throughout the study.
Number of Participants With Treatment Emergent Treatment Related AEs and SAEs Participants with Adverse Events	47 Participants	11 Participants	1 Participants	2 Participants
Number of Participants With Treatment Emergent Treatment Related AEs and SAEs Participants with Serious Adverse Events	28 Participants	5 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years)

Population: Tafamidis treated set included participants who were on tafamidis at or prior to the enrollment, as well as participants who were not on tafamidis at enrollment but subsequently initiated tafamidis treatment during the study. Tafamidis untreated set included participants who were enrolled and never received tafamidis throughout the study, as well as participants who were not on tafamidis before or at enrollment but subsequently initiated tafamidis treatment during the study.

Number of deaths due to any cause was analyzed as time from enrollment or first treatment of tafamidis.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=2521 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=5686 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Number of All-Cause Deaths	158 Participants	1038 Participants	—	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set:all enrolled participants in THAOS study.Tafamidis treated set:participants who were on tafamidis at or prior to the enrollment, as well as those who were not on tafamidis at enrollment but subsequently received tafamidis during the study.Tafamidis untreated set:participants who were enrolled and never received tafamidis throughout the study, as well as those who were not on tafamidis before or at enrollment but subsequently started tafamidis treatment during the study.

Modified Polyneuropathy Disability (mPND) is a score that categorizes participants into six stages (0, I,II, IIIa, IIIb, IV) based on mobility status. 0 = No sensory disturbances in the feet and able to walk without difficulty; I=Sensory disturbances in the feet but able to walk without difficulty; II=Some difficulties with walking but can walk without aid; IIIa=Able to walk with 1 stick or crutch; IIIb=Able to walk with 2 sticks or crutches; IV=Not ambulatory, confined to a wheelchair or bedridden. Higher stage indicates lower mobility status.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=4434 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=1689 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=3785 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Number of Participants With Modified Polyneuropathy Disability (mPND) Scores at Baseline 0	1860 Participants	512 Participants	1731 Participants	—
Number of Participants With Modified Polyneuropathy Disability (mPND) Scores at Baseline I	1642 Participants	785 Participants	1372 Participants	—
Number of Participants With Modified Polyneuropathy Disability (mPND) Scores at Baseline II	492 Participants	255 Participants	349 Participants	—
Number of Participants With Modified Polyneuropathy Disability (mPND) Scores at Baseline IIIa	226 Participants	84 Participants	160 Participants	—
Number of Participants With Modified Polyneuropathy Disability (mPND) Scores at Baseline IIIb	136 Participants	37 Participants	106 Participants	—
Number of Participants With Modified Polyneuropathy Disability (mPND) Scores at Baseline IV	78 Participants	16 Participants	67 Participants	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set:all enrolled participants in THAOS study.Tafamidis treated set:participants who were on tafamidis at or prior to the enrollment, as well as those who were not on tafamidis at enrollment but subsequently received tafamidis during the study.Tafamidis untreated set:participants who were enrolled and never received tafamidis throughout the study, as well as those who were not on tafamidis before or at enrollment but subsequently started tafamidis treatment during the study.

Coutinho disease stages is the most common classification used to capture ATTR (Transthyretin Amyloidosis) disease progression. Participants with stage 0 disease are asymptomatic, Participants with stage 1 (mild) disease are ambulatory, Participants with stage 2 (moderate) disease are ambulatory but require assistance and/or have involvement of the upper limbs, and Participants with stage 3 (severe) disease are bedridden or wheelchair-bound.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=4434 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=1689 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=3785 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Number of Participants With Coutinho Disease Stages at Baseline Stage 0	1860 Participants	512 Participants	1731 Participants	—
Number of Participants With Coutinho Disease Stages at Baseline Stage 1	2134 Participants	1040 Participants	1721 Participants	—
Number of Participants With Coutinho Disease Stages at Baseline Stage 2	362 Participants	121 Participants	266 Participants	—
Number of Participants With Coutinho Disease Stages at Baseline Stage 3	78 Participants	16 Participants	67 Participants	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set:all enrolled participants in THAOS study.Tafamidis treated set:participants who were on tafamidis at or prior to the enrollment, as well as those who were not on tafamidis at enrollment but subsequently received tafamidis during the study.Tafamidis untreated set:participants who were enrolled and never received tafamidis throughout the study, as well as those who were not on tafamidis before or at enrollment but subsequently started tafamidis treatment during the study.

Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 10 level score which ranges between 10 (moribund) to 100 (normal, no evidence of disease). Higher score means higher ability to perform daily tasks.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=4764 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=1895 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=3998 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Number of Participants With Karnofsky Performance Index at Baseline 10	2 Participants	1 Participants	2 Participants	—
Number of Participants With Karnofsky Performance Index at Baseline 20	6 Participants	0 Participants	6 Participants	—
Number of Participants With Karnofsky Performance Index at Baseline 30	6 Participants	3 Participants	3 Participants	—
Number of Participants With Karnofsky Performance Index at Baseline 40	82 Participants	15 Participants	71 Participants	—
Number of Participants With Karnofsky Performance Index at Baseline 50	140 Participants	31 Participants	121 Participants	—
Number of Participants With Karnofsky Performance Index at Baseline 60	271 Participants	92 Participants	209 Participants	—
Number of Participants With Karnofsky Performance Index at Baseline 70	492 Participants	200 Participants	375 Participants	—
Number of Participants With Karnofsky Performance Index at Baseline 80	944 Participants	436 Participants	728 Participants	—
Number of Participants With Karnofsky Performance Index at Baseline 90	1127 Participants	633 Participants	890 Participants	—
Number of Participants With Karnofsky Performance Index at Baseline 100	1694 Participants	484 Participants	1593 Participants	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set:all enrolled participants in THAOS study.Tafamidis treated set:participants who were on tafamidis at or prior to the enrollment, as well as those who were not on tafamidis at enrollment but subsequently received tafamidis during the study.Tafamidis untreated set:participants who were enrolled and never received tafamidis throughout the study, as well as those who were not on tafamidis before or at enrollment but subsequently started tafamidis treatment during the study.

Heart failure, also known as congestive heart failure is a cardiovascular event.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=6718 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=2521 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=5686 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Number of Participants With Heart Failure at Baseline	2717 Participants	1125 Participants	2245 Participants	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set:all enrolled participants in THAOS study.Tafamidis treated set:participants who were on tafamidis at or prior to the enrollment, as well as those who were not on tafamidis at enrollment but subsequently received tafamidis during the study.Tafamidis untreated set:participants who were enrolled and never received tafamidis throughout the study, as well as those who were not on tafamidis before or at enrollment but subsequently started tafamidis treatment during the study.

New York Health Association (NYHA) functional classification included: Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity; fatigue, palpitation, or dyspnea with ordinary physical activity), Class III (marked limitation of physical activity; fatigue, palpitation, or dyspnea with less than ordinary physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest).

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=2380 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=922 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=1963 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Number of Participants With New York Heart Association (NYHA) Classifications at Baseline I	304 Participants	133 Participants	252 Participants	—
Number of Participants With New York Heart Association (NYHA) Classifications at Baseline II	1341 Participants	557 Participants	1088 Participants	—
Number of Participants With New York Heart Association (NYHA) Classifications at Baseline III	664 Participants	222 Participants	556 Participants	—
Number of Participants With New York Heart Association (NYHA) Classifications at Baseline IV	71 Participants	10 Participants	67 Participants	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set:all enrolled participants in THAOS study.Tafamidis treated set:participants who were on tafamidis at or prior to the enrollment, as well as those who were not on tafamidis at enrollment but subsequently received tafamidis during the study.Tafamidis untreated set:participants who were enrolled and never received tafamidis throughout the study, as well as those who were not on tafamidis before or at enrollment but subsequently started tafamidis treatment during the study.

Participants diagnosed with Transthyretin Amyloidosis (ATTR) at baseline with assessed category of yes, no, and unknown.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=6035 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=2408 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=5046 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Number of Participants Diagnosed With ATTR at Baseline Yes	4773 Participants	2368 Participants	3794 Participants	—
Number of Participants Diagnosed With ATTR at Baseline No	1234 Participants	36 Participants	1227 Participants	—
Number of Participants Diagnosed With ATTR at Baseline Unknown	28 Participants	4 Participants	25 Participants	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set:all enrolled participants in THAOS study.Tafamidis treated set:participants who were on tafamidis at or prior to the enrollment, as well as those who were not on tafamidis at enrollment but subsequently received tafamidis during the study.Tafamidis untreated set:participants who were enrolled and never received tafamidis throughout the study, as well as those who were not on tafamidis before or at enrollment but subsequently started tafamidis treatment during the study.

Number of participants with ATTR and participants who had prior misdiagnosis at the baseline were reported.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=6718 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=2521 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=5686 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Number of Participants With Prior Misdiagnosis at Baseline	616 Participants	283 Participants	493 Participants	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set:all enrolled participants in THAOS study.Tafamidis treated set:participants who were on tafamidis at or prior to the enrollment, as well as those who were not on tafamidis at enrollment but subsequently received tafamidis during the study.Tafamidis untreated set:participants who were enrolled and never received tafamidis throughout the study, as well as those who were not on tafamidis before or at enrollment but subsequently started tafamidis treatment during the study.

Genetic mutation leads to misfolding of protein transthyretin (TTR) which results in ATTR. In this outcome, number of participants with ATTRv mutation type and wild type TTR were reported.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=6718 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=2521 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=5686 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Number of Participants With ATTR Genotypes at Baseline ATTRv mutation	4950 Participants	1743 Participants	4365 Participants	—
Number of Participants With ATTR Genotypes at Baseline Wild type	1768 Participants	778 Participants	1321 Participants	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set:all enrolled participants in THAOS study.Tafamidis treated set:participants who were on tafamidis at or prior to the enrollment, as well as those who were not on tafamidis at enrollment but subsequently received tafamidis during the study.Tafamidis untreated set:participants who were enrolled and never received tafamidis throughout the study, as well as those who were not on tafamidis before or at enrollment but subsequently started tafamidis treatment during the study.

Number of participants had previous or current participant in any clinical trials at the baseline.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=5270 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=2149 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=4273 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Number of Participants With Past or Current Clinical Trial Participation at Baseline Yes	853 Participants	473 Participants	669 Participants	—
Number of Participants With Past or Current Clinical Trial Participation at Baseline No	4417 Participants	1676 Participants	3604 Participants	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set:all enrolled participants in THAOS study.Tafamidis treated set:participants who were on tafamidis at or prior to the enrollment, as well as those who were not on tafamidis at enrollment but subsequently received tafamidis during the study.Tafamidis untreated set:participants who were enrolled and never received tafamidis throughout the study, as well as those who were not on tafamidis before or at enrollment but subsequently started tafamidis treatment during the study.

Number of participants being allowed for the use of Tafamidis when under strict conditions, Tafamidis was in development and made available to groups of participants who have a disease with no satisfactory authorised therapies and who cannot enter clinical trials.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=3267 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=1490 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=2461 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Number of Participants With Past or Current Tafamidis Compassionate Use/Early Access or Other Non-commercial Program at Baseline Yes	85 Participants	80 Participants	38 Participants	—
Number of Participants With Past or Current Tafamidis Compassionate Use/Early Access or Other Non-commercial Program at Baseline No	3182 Participants	1410 Participants	2423 Participants	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set:all enrolled participants in THAOS study.Tafamidis treated set:participants who were on tafamidis at or prior to the enrollment, as well as those who were not on tafamidis at enrollment but subsequently received tafamidis during the study.Tafamidis untreated set:participants who were enrolled and never received tafamidis throughout the study, as well as those who were not on tafamidis before or at enrollment but subsequently started tafamidis treatment during the study.

Number of participants whether with family history of symptomatic ATTR amyloidosis at Baseline were reported.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=6676 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=2513 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=5652 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Number of Participants With Known Family History of Symptomatic ATTR at Baseline Yes	3874 Participants	1365 Participants	3485 Participants	—
Number of Participants With Known Family History of Symptomatic ATTR at Baseline No	2243 Participants	873 Participants	1792 Participants	—
Number of Participants With Known Family History of Symptomatic ATTR at Baseline Unknown	559 Participants	275 Participants	375 Participants	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set:all enrolled participants in THAOS study.Tafamidis treated set:participants who were on tafamidis at or prior to the enrollment, as well as those who were not on tafamidis at enrollment but subsequently received tafamidis during the study.Tafamidis untreated set:participants who were enrolled and never received tafamidis throughout the study, as well as those who were not on tafamidis before or at enrollment but subsequently started tafamidis treatment during the study.

The mean of affected generations in participants with a known family history was reported.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=3730 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=1337 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=3344 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Number of Affected Generations at Baseline	1.5 Generation Standard Deviation 0.95	1.5 Generation Standard Deviation 1.01	1.5 Generation Standard Deviation 0.96	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set:all enrolled participants in THAOS study.Tafamidis treated set:participants who were on tafamidis at or prior to the enrollment, as well as those who were not on tafamidis at enrollment but subsequently received tafamidis during the study.Tafamidis untreated set:participants who were enrolled and never received tafamidis throughout the study, as well as those who were not on tafamidis before or at enrollment but subsequently started tafamidis treatment during the study.

Neuropathy Impairment Score - Lower Limb (NIS-LL) assessed motor, sensory and reflex activity specifically in the lower limbs and combined total scores for the lower limbs were collected and reported. Derived NIS LL score extends from 0 (normal functions) to a maximum possible value of 88 points, the scale is additive for all deficits and is applied bilaterally for each modality tested: 1) muscle strength: 0 (normal)-4 (paralysis), higher score = more weakness; 2) sensory and 3) reflex testings: 0=normal, 1=decreased, or 2=absent. Reflex score: 0 (normal)-10 (present), higher score =present in more anatomic sites; Motor score: 0-160 (full range of motion with maximum resistance across all anatomical sites), higher score=more impairment. Sensory Score has a range of 0 to the normal value of 124 where ratings are coded as 0=absent; 1=decreased; 2=normal.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=6718 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=2521 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=5686 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Derived Neuropathy Impairment Score-Lower Limb (NIS-LL) at Baseline Derived NIS-LL Score	14.0 Score on a scale Standard Deviation 20.73	20.3 Score on a scale Standard Deviation 20.17	12.7 Score on a scale Standard Deviation 20.14	—
Derived Neuropathy Impairment Score-Lower Limb (NIS-LL) at Baseline Reflex Score	8.2 Score on a scale Standard Deviation 3.05	7.5 Score on a scale Standard Deviation 3.13	8.3 Score on a scale Standard Deviation 2.94	—
Derived Neuropathy Impairment Score-Lower Limb (NIS-LL) at Baseline Motor Score	152.2 Score on a scale Standard Deviation 19.11	150.6 Score on a scale Standard Deviation 18.98	152.8 Score on a scale Standard Deviation 18.41	—
Derived Neuropathy Impairment Score-Lower Limb (NIS-LL) at Baseline Sensory Score	108.2 Score on a scale Standard Deviation 25.83	97.6 Score on a scale Standard Deviation 26.79	109.4 Score on a scale Standard Deviation 25.19	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set:all enrolled participants in THAOS study.Tafamidis treated set:participants who were on tafamidis at or prior to the enrollment, as well as those who were not on tafamidis at enrollment but subsequently received tafamidis during the study.Tafamidis untreated set:participants who were enrolled and never received tafamidis throughout the study, as well as those who were not on tafamidis before or at enrollment but subsequently started tafamidis treatment during the study.

BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2).

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=6512 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=2485 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=5494 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Body Mass Index (BMI) at Baseline	26.3 kg/m^2 Standard Deviation 17.93	26.5 kg/m^2 Standard Deviation 24.14	25.9 kg/m^2 Standard Deviation 11.12	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set:all enrolled participants in THAOS study.Tafamidis treated set:participants who were on tafamidis at or prior to the enrollment, as well as those who were not on tafamidis at enrollment but subsequently received tafamidis during the study.Tafamidis untreated set:participants who were enrolled and never received tafamidis throughout the study, as well as those who were not on tafamidis before or at enrollment but subsequently started tafamidis treatment during the study.

mBMI was calculated by multiplying BMI by serum albumin levels [gram/liter (g/L)]. mBMI was measured as kg/m^2*g/L. A progressive decline in mBMI indicated worsening of disease severity.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=4370 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=1846 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=3672 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Modified Body Mass Index (mBMI) at Baseline	1078 (kg/m^2)*(g/L) Standard Deviation 240.9	1063.1 (kg/m^2)*(g/L) Standard Deviation 228.8	1083.3 (kg/m^2)*(g/L) Standard Deviation 242.4	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall:all available data from enrolled participants.Tafamidis treated:available data from enrolled participants that were on tafamidis at or prior to the enrollment,and those not on tafamidis at the enrollment but later initiated tafamidis.Tafamidis untreated:available data from enrolled participants and did not receive tafamidis throughout and those not on tafamidis prior or at enrollment but later initiated tafamidis.Number analyzed=participants with available BP data collected at baseline.

BP (Blood Pressure) is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). Available sitting SBP and DBP at Baseline were reported.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=6718 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=2473 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=5686 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Sitting Systolic and Diastolic Blood Pressures (SBP and DBP) at Baseline Sitting Systolic BP (mmHg)	123.7 mmHg Standard Deviation 18.67	125.3 mmHg Standard Deviation 18.78	122.9 mmHg Standard Deviation 18.15	—
Sitting Systolic and Diastolic Blood Pressures (SBP and DBP) at Baseline Sitting Diastolic BP (mmHg)	75.3 mmHg Standard Deviation 11.69	75.6 mmHg Standard Deviation 11.56	75.1 mmHg Standard Deviation 11.58	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set: All available data from enrolled participants in THAOS study. Tafamidis treated set: All available data from participants enrolled in THAOS that were on tafamidis at and prior to the enrollment; participant not on tafamidis at the enrollment subsequently initiated treatment. Tafamidis untreated set: All available data from participants enrolled in THAOS and did not receive tafamidis during the study, including those initiated receiving tafamidis post enrollment.

Cardiac amyloidosis is attributable to intramyocardial amyloid infiltration, which leads to a progressive increase of ventricular wall thickness and stiffness. A left ventricular (LV) wall thickness ≥12 mm plus at least one red flag should raise the suspicion of cardiac amyloidosis.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=3036 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=1298 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=2429 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Left Ventricular (LV) Septum Thickness at Baseline	15.2 mm Standard Deviation 5.27	15.3 mm Standard Deviation 4.31	15.2 mm Standard Deviation 5.52	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set: All available data from enrolled participants in THAOS study. Tafamidis treated set: All available data from participants enrolled in THAOS that were on tafamidis at and prior to the enrollment; participant not on tafamidis at the enrollment subsequently initiated treatment. Tafamidis untreated set: All available data from participants enrolled in THAOS and did not receive tafamidis during the study, including those initiated receiving tafamidis post enrollment.

Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=2907 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=1263 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=2301 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Left Ventricular (LV) Ejection Fraction at Baseline	53.6 Percentage Standard Deviation 13.46	54.3 Percentage Standard Deviation 12.61	53.5 Percentage Standard Deviation 13.77	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set: All available data from enrolled participants in THAOS study. Tafamidis treated set: All available data from participants enrolled in THAOS that were on tafamidis at and prior to the enrollment; participant not on tafamidis at the enrollment subsequently initiated treatment. Tafamidis untreated set: All available data from participants enrolled in THAOS and did not receive tafamidis during the study, including those initiated receiving tafamidis post enrollment.

EQ-5D-3L VAS: participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. The VAS component rated the current health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=4478 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=1709 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=3910 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Euro Quality of Life-5 Dimensions-3 Level (EQ-5D-3L): Visual Analog Scale (VAS) Overall Health Score at Baseline	71.0 Score on a scale Standard Deviation 20.80	70.2 Score on a scale Standard Deviation 20.01	71.7 Score on a scale Standard Deviation 20.98	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set:all enrolled participants in THAOS study.Tafamidis treated set:participants who were on tafamidis at or prior to the enrollment, as well as those who were not on tafamidis at enrollment but subsequently received tafamidis during the study.Tafamidis untreated set:participants who were enrolled and never received tafamidis throughout the study, as well as those who were not on tafamidis before or at enrollment but subsequently started tafamidis treatment during the study.

The EQ-5D-3L VAS derived index is calculated by subtracting the values of the descriptive EQ-5D system from the numerical value. This corresponds to the best possible health status, the scale of the Derived Index is 0 [death] to 1 [perfect health]. EQ-5D-3L VAS overall health score and derived score data were sourced from different part of the EQ-5D questionnaire and are conceptually different from each other as EQ VAS is a 0-100 scale and EQ-5D index is a value attached to an EQ-5D profile according to a set of weights that reflect, on average, participant's preferences about how good or bad the state is. More data were collected for EQ-5D index score compared to EQ VAS overall health score at the baseline.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=4550 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=1736 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=3969 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
EQ-5D-3L: VAS Derived Index at Baseline	0.8 Score on a scale Standard Deviation 0.20	0.8 Score on a scale Standard Deviation 0.19	0.8 Score on a scale Standard Deviation 0.20	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set: All available data from enrolled participants in THAOS study. Tafamidis treated set: All available data from participants enrolled in THAOS that were on tafamidis at and prior to the enrollment; participant not on tafamidis at the enrollment subsequently initiated treatment. Tafamidis untreated set: All available data from participants enrolled in THAOS and did not receive tafamidis during the study, including those initiated receiving tafamidis post enrollment.

Norfolk QOL: 35-item participant-rated questionnaire used to assess impact of neuropathy on the quality of life of participants diagnosed with ATTR. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: activities of daily living, large fiber neuropathy/physical functioning, small fiber neuropathy, autonomic neuropathy, and symptoms. TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=4605 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=1795 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=4002 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Norfolk Total Quality of Life (QoL) Score at Baseline	24.3 Score on a scale Standard Deviation 28.10	25.2 Score on a scale Standard Deviation 27.30	23.1 Score on a scale Standard Deviation 27.90	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set: All available data from enrolled participants in THAOS study. Tafamidis treated set: All available data from participants enrolled in THAOS that were on tafamidis at and prior to the enrollment; participant not on tafamidis at the enrollment subsequently initiated treatment. Tafamidis untreated set: All available data from participants enrolled in THAOS and did not receive tafamidis during the study, including those initiated receiving tafamidis post enrollment.

Following parameters were analyzed: heart rate, PR interval, QT interval, QRS interval and QT interval corrected using Fridericia's formula (QTcF). Abnormal findings in ECG were based on investigator's discretion.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=6718 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=2521 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=5686 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Number of Participants With Abnormal Electrocardiogram (ECG) at Baseline	2911 Participants	1226 Participants	2315 Participants	—

SECONDARY outcome

Timeframe: At the start of data collection at Baseline (Day 1)

Population: Overall analysis set: All available data from enrolled participants in THAOS study. Tafamidis treated set: All available data from participants enrolled in THAOS that were on tafamidis at and prior to the enrollment; participant not on tafamidis at the enrollment subsequently initiated treatment. Tafamidis untreated set: All available data from participants enrolled in THAOS and did not receive tafamidis during the study, including those initiated receiving tafamidis post enrollment.

Number of participants with atrial fibrillation/flutter (rapid, irregular heart rhythm), implanted artificial cardiac pacemaker, and implantable cardioverter-defibrillator (ICD) (detects and stops irregular heartbeats, also called arrhythmias) were reported.

Outcome measures

Measure	Tafamidis 20 mg Treated-Overall n=6718 Participants All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=2521 Participants All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=5686 Participants All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall All available data from participants who received any other dose of Tafamidis throughout the study.
Number of Participants With Atrial Fibrillation/Flutter, Pacemaker Implanted, and Implantable Cardioverter/Defibrillator (ICD) at Baseline Atrial Fibrillation/Flutter	667 Participants	290 Participants	501 Participants	—
Number of Participants With Atrial Fibrillation/Flutter, Pacemaker Implanted, and Implantable Cardioverter/Defibrillator (ICD) at Baseline Pacemaker Implanted	364 Participants	167 Participants	266 Participants	—
Number of Participants With Atrial Fibrillation/Flutter, Pacemaker Implanted, and Implantable Cardioverter/Defibrillator (ICD) at Baseline ICD Implanted	127 Participants	62 Participants	99 Participants	—

Adverse Events

Tafamidis 20 mg Treated-Overall

Serious events: 333 serious events

Other events: 94 other events

Deaths: 197 deaths

Tafamidis 61/80 mg Treated-Overall

Serious events: 138 serious events

Other events: 3 other events

Deaths: 81 deaths

Tafamidis 20 mg to 61/80 mg Treated-Overall

Serious events: 41 serious events

Other events: 0 other events

Deaths: 12 deaths

Tafamidis Other Treated-Overall

Serious events: 3 serious events

Other events: 1 other events

Deaths: 4 deaths

Tafamidis Untreated

Serious events: 4 serious events

Other events: 0 other events

Deaths: 939 deaths

Serious adverse events

Measure	Tafamidis 20 mg Treated-Overall n=1648 participants at risk All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=662 participants at risk All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=196 participants at risk All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall n=15 participants at risk All available data from participants who received any other dose of Tafamidis throughout the study.	Tafamidis Untreated n=4197 participants at risk All available data from participants who had been enrolled in THAOS, signed the informed consent and who had not received tafamidis during the THAOS study.
Investigations Heart rate decreased	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Blood and lymphatic system disorders Anaemia	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.30% 2/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Acute coronary syndrome	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Congenital, familial and genetic disorders Familial amyloidosis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Endocrine disorders Hyperthyroidism	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Eye disorders Cataract	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Asthenia	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.45% 3/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Hepatobiliary disorders Biliary colic	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Immune system disorders Amyloidosis	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Abscess limb	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Ankle fracture	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Investigations Blood creatinine increased	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Metabolism and nutrition disorders Cachexia	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Brain injury	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Psychiatric disorders Bipolar disorder	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Renal and urinary disorders Acute kidney injury	0.30% 5/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	1.8% 12/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	1.5% 3/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Skin and subcutaneous tissue disorders Angioedema	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Social circumstances Pregnancy of partner	0.49% 8/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Surgical and medical procedures Abdominal cavity drainage	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Vascular disorders Aortic stenosis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Blood and lymphatic system disorders Coagulopathy	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Blood and lymphatic system disorders Febrile bone marrow aplasia	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Acute left ventricular failure	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.45% 3/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Acute myocardial infarction	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.30% 2/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Angina unstable	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Aortic valve disease	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.30% 2/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Arrhythmia	0.30% 5/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.76% 5/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Atrial fibrillation	0.24% 4/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	1.1% 7/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	1.5% 3/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Atrial flutter	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	1.0% 2/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Atrial tachycardia	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Atrioventricular block	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Atrioventricular block complete	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.91% 6/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	1.0% 2/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Vascular disorders Deep vein thrombosis	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Atrioventricular block second degree	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Atrioventricular dissociation	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Bradycardia	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Bundle branch block left	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Cardiac amyloidosis	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.30% 2/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.02% 1/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Cardiac arrest	0.36% 6/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	1.2% 8/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Cardiac disorder	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Cardiac failure	2.1% 34/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 32/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	9.2% 18/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.02% 1/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Cardiac failure acute	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.60% 4/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Cardiac failure chronic	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Cardiac failure congestive	0.91% 15/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.1% 14/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	6.7% 1/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Cardiac tamponade	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Cardio-respiratory arrest	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Cardiogenic shock	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Cardiomyopathy acute	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Cardiorenal syndrome	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Conduction disorder	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Coronary artery disease	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.45% 3/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Coronary artery stenosis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Defect conduction intraventricular	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Left ventricular dysfunction	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Mitral valve incompetence	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.30% 2/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Myocardial infarction	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.30% 2/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Myocardial ischaemia	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Pericardial effusion	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Pericarditis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Pulseless electrical activity	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Right ventricular failure	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Sinoatrial block	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Sinus node dysfunction	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.30% 2/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.02% 1/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Stress cardiomyopathy	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Tachycardia	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Torsade de pointes	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Tricuspid valve incompetence	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Ventricular fibrillation	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Cardiac disorders Ventricular tachycardia	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Congenital, familial and genetic disorders Hereditary neuropathic amyloidosis	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Congenital, familial and genetic disorders Hydrocele	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Congenital, familial and genetic disorders Hypertrophic cardiomyopathyv	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Eye disorders Glaucoma	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Eye disorders Retinal artery occlusion	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Eye disorders Visual impairment	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Eye disorders Vitreous haemorrhage	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Abdominal pain	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Abdominal pain upper	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Anal fistula	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Anal haemorrhage	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Ascites	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Constipation	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Diarrhoea	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.30% 2/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Dyspepsia	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Enteritis	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Faecaloma	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Gastritis	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.45% 3/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Haematemesis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Haematochezia	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Ileus	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Ileus paralytic	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Intestinal obstruction	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Intestinal perforation	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Nausea	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Oesophageal perforation	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Oesophagitis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Pancreatitis acute	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Pancreatolithiasis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Portal hypertensive gastropathy	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Umbilical hernia	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Vomiting	0.67% 11/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Chest pain	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.45% 3/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Death	0.49% 8/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	1.7% 11/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.0% 4/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	6.7% 1/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.02% 1/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Disease progression	0.49% 8/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Drug ineffective	0.97% 16/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Drug intolerance	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Fatigue	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Gait disturbance	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders General physical health deterioration	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Generalised oedema	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Malaise	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Multi-organ disorder	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Multiple organ dysfunction syndrome	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Oedema	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Oedema peripheral	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Pain	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.30% 2/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Pyrexia	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Sudden cardiac death	0.36% 6/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Sudden death	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Hepatobiliary disorders Biliary fistula	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Hepatobiliary disorders Cholangitis	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Hepatobiliary disorders Cholangitis acute	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Hepatobiliary disorders Cholecystitis	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Hepatobiliary disorders Cholecystitis acute	0.24% 4/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Hepatobiliary disorders Cholelithiasis	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.30% 2/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Hepatobiliary disorders Congestive hepatopathy	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Hepatobiliary disorders Hepatic artery thrombosis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Hepatobiliary disorders Hepatic function abnormal	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Hepatobiliary disorders Hepatitis toxic	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Hepatobiliary disorders Portal vein thrombosis	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Anal abscess	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Appendicitis	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Arthritis infective	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations COVID-19	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations COVID-19 pneumonia	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Cellulitis	0.49% 8/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.30% 2/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Chikungunya virus infection	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Clostridium colitis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Cystitis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Diverticulitis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Endocarditis	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Escherichia urinary tract infection	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Gastroenteritis	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Gastroenteritis viral	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Hepatitis B	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Infected skin ulcer	0.30% 5/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Infection	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Infectious mononucleosis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Infective keratitis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Intervertebral discitis	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.30% 2/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Klebsiella urinary tract infection	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Large intestine infection	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Localised infection	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Necrotising fasciitis	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Oesophageal candidiasis	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Osteomyelitis	0.49% 8/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Peritoneal abscess	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Peritonitis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Peritonitis bacterial	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Plasmodium falciparum infection	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Pneumonia	0.79% 13/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.91% 6/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Pneumonia aspiration	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Pneumonia bacterial	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Pneumonia influenzal	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Postoperative wound infection	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Proteus infection	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Pulmonary sepsis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Pulmonary tuberculosis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Pyelonephritis	0.49% 8/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Pyelonephritis acute	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Sepsis	0.61% 10/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.30% 2/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	1.0% 2/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Septic shock	0.24% 4/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Skin infection	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Staphylococcal bacteraemia	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Tooth infection	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Tracheobronchitis	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Tuberculous pleurisy	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Upper respiratory tract infection	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Urinary bladder abscess	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Urinary tract infection	0.73% 12/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Urinary tract infection bacterial	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Urinary tract infection enterococcal	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Urinary tract infection pseudomonal	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Urosepsis	0.30% 5/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.30% 2/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Vascular device infection	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Wound infection	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Burns third degree	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Complications of transplanted liver	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Contusion	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Fall	0.24% 4/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	1.0% 2/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Femoral neck fracture	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Femur fracture	0.30% 5/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Fibula fracture	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Foot fracture	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Head injury	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Hip fracture	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Humerus fracture	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Joint dislocation	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Liver transplant failure	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Lower limb fracture	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Meniscus injury	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Multiple fractures	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Radius fracture	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Reactive gastropathy	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Road traffic accident	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Shoulder fracture	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Spinal compression fracture	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Subdural haematoma	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Thermal burn	0.24% 4/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Tibia fracture	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Toxicity to various agents	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Transplant dysfunction	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Transplantation complication	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Wound	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Wound complication	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Investigations Liver function test abnormal	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Investigations SARS-CoV-2 test positive	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.45% 3/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Investigations Troponin increased	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Metabolism and nutrition disorders Dehydration	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Metabolism and nutrition disorders Enzyme abnormality	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Metabolism and nutrition disorders Feeding intolerance	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Metabolism and nutrition disorders Gout	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.45% 3/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.30% 2/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Metabolism and nutrition disorders Hyperkalaemia	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.30% 2/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Metabolism and nutrition disorders Hypoalbuminaemia	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Metabolism and nutrition disorders Hypoglycaemia	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Metabolism and nutrition disorders Hypokalaemia	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Metabolism and nutrition disorders Hyponatraemia	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.30% 2/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Metabolism and nutrition disorders Malnutrition	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Arthritis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Back pain	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.45% 3/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Myopathy	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.30% 2/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Osteitis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Osteoarthropathy	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Spondyloarthropathy	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma metastatic	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papillary-mucinous carcinoma of pancreas	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelofibrosis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oligodendroglioma	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural neoplasm	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.02% 1/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.30% 2/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer metastatic	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.02% 1/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Cerebral haemorrhage	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Cerebral infarction	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Cerebral ischaemia	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Cerebrovascular accident	0.24% 4/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.60% 4/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Coma	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Dizziness	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Embolic stroke	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Encephalopathy	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Headache	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Ischaemic stroke	0.42% 7/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Lumbosacral radiculopathy	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Myelopathy	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Neuropathy peripheral	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Polyneuropathy	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Restless legs syndrome	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Sciatica	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Serotonin syndrome	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Status epilepticus	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Syncope	0.49% 8/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.76% 5/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	1.0% 2/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	6.7% 1/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.85% 14/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Psychiatric disorders Depression	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	6.7% 1/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Psychiatric disorders Mental status changes	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Psychiatric disorders Psychotic disorder	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Psychiatric disorders Suicidal ideation	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Renal and urinary disorders Anuria	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Renal and urinary disorders Chronic kidney disease	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Renal and urinary disorders Dysuria	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Renal and urinary disorders End stage renal disease	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Renal and urinary disorders Haematuria	0.24% 4/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Renal and urinary disorders Nephrolithiasis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Renal and urinary disorders Renal failure	0.24% 4/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Renal and urinary disorders Renal impairment	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Renal and urinary disorders Ureterolithiasis	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Renal and urinary disorders Urethral obstruction	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Renal and urinary disorders Urethral stenosis	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Renal and urinary disorders Urinary retention	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	1.0% 2/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Reproductive system and breast disorders Cervical dysplasia	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Reproductive system and breast disorders Intermenstrual bleeding	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Reproductive system and breast disorders Prostatitis	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Reproductive system and breast disorders Spermatocele	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Reproductive system and breast disorders Vaginal haemorrhage	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.24% 4/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.60% 4/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.30% 2/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.0% 4/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.18% 3/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.24% 4/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Skin and subcutaneous tissue disorders Cutaneous vasculitis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Skin and subcutaneous tissue disorders Pemphigoid	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Skin and subcutaneous tissue disorders Skin ulcer	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Surgical and medical procedures Abortion induced	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Surgical and medical procedures Cardiac pacemaker replacement	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Surgical and medical procedures Liver transplant	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Vascular disorders Circulatory collapse	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Vascular disorders Extremity necrosis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Vascular disorders Haematoma	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Vascular disorders Hypertension	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.51% 1/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Vascular disorders Hypotension	0.12% 2/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	1.0% 2/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Vascular disorders Hypovolaemic shock	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Vascular disorders Orthostatic hypotension	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Vascular disorders Peripheral artery occlusion	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.15% 1/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Vascular disorders Shock haemorrhagic	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Vascular disorders Superficial vein thrombosis	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Vascular disorders Superior vena cava syndrome	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Immune system disorders Amyloidosis senile	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.02% 1/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Immune system disorders Heart transplant rejection	0.06% 1/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.00% 0/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.02% 1/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.

Other adverse events

Measure	Tafamidis 20 mg Treated-Overall n=1648 participants at risk All available data from participants who received Tafamidis 20 mg throughout the study.	Tafamidis 61/80 mg Treated-Overall n=662 participants at risk All available data from participants who received Tafamidis 61/80 mg (Tafamidis 61mg/tafamidis meglumine 80 mg) throughout the study.	Tafamidis 20 mg to 61/80 mg Treated-Overall n=196 participants at risk All available data from participants who received Tafamidis 20 mg but switched to 61/80 mg during the study.	Tafamidis Other Treated-Overall n=15 participants at risk All available data from participants who received any other dose of Tafamidis throughout the study.	Tafamidis Untreated n=4197 participants at risk All available data from participants who had been enrolled in THAOS, signed the informed consent and who had not received tafamidis during the THAOS study.
Infections and infestations Urinary tract infection	5.7% 94/1648 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.45% 3/662 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/196 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	6.7% 1/15 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/4197 • From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.

Additional Information

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Results disclosure agreements

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