Trial Outcomes & Findings for A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3) (NCT NCT03112603)

NCT ID: NCT03112603

Last Updated: 2025-08-12

Results Overview

ORR was defined as the percentage of participants in each arm demonstrating a complete response (CR) or partial response (PR) based on chronic GvHD (cGvHD) disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response. Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 330 participants
• Primary outcome timeframe: Cycle 7 Day 1 (each cycle was comprised of 4 weeks)
• Results posted on: 2025-08-12

Participant Flow

The study was conducted in 29 countries globally. During the main treatment period, participants were randomly assigned to a ruxolitinib arm or a Best Available Therapy (BAT) arm for 6 cycles of treatment. At the end of Cycle 6, participants in the BAT arm either crossed over to ruxolitinib treatment or entered the survival follow-up phase.

A total of 404 participants were screened, of whom 72 were screen failures and 3 were not randomized for various reasons. Out of the 329 participants randomized, 6 did not receive BAT due to logistical reasons. A total of 329 participants were included in the Full Analysis Set (FAS); 165 were in the ruxolitinib arm and 164 were in the BAT arm.

Participant milestones

Measure	Ruxolitinib Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
End of Randomization Period STARTED	165	164	0
End of Randomization Period COMPLETED	29	24	0
End of Randomization Period NOT COMPLETED	136	140	0
End of Cross Over Period STARTED	0	0	70
End of Cross Over Period COMPLETED	0	0	16
End of Cross Over Period NOT COMPLETED	0	0	54

Reasons for withdrawal

Measure	Ruxolitinib Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
End of Randomization Period Lost to Follow-up	3	0	0
End of Randomization Period Participant/Guardian Decision	7	14	0
End of Randomization Period Physician Decision	43	18	0
End of Randomization Period Failure to Meet Protocol Continuation Criteria	4	5	0
End of Randomization Period Death	10	7	0
End of Randomization Period Disease Relapse	12	7	0
End of Randomization Period Lack of Efficacy	25	77	0
End of Randomization Period Adverse Event	32	12	0
End of Cross Over Period Death	0	0	2
End of Cross Over Period Participant/Guardian Decision	0	0	7
End of Cross Over Period Physician Decision	0	0	29
End of Cross Over Period Lack of Efficacy	0	0	8
End of Cross Over Period Adverse Event	0	0	6
End of Cross Over Period Disease Relapse	0	0	2

Baseline Characteristics

A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)

Baseline characteristics by cohort

Measure	Ruxolitinib n=165 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy n=164 Participants Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Total n=329 Participants Total of all reporting groups
Age, Continuous	45.9 Years STANDARD_DEVIATION 15.68 • n=5 Participants	47.2 Years STANDARD_DEVIATION 16.17 • n=7 Participants	46.5 Years STANDARD_DEVIATION 15.92 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	72 Participants n=7 Participants	128 Participants n=5 Participants
Sex: Female, Male Male	109 Participants n=5 Participants	92 Participants n=7 Participants	201 Participants n=5 Participants
Race/Ethnicity, Customized White	116 Participants n=5 Participants	132 Participants n=7 Participants	248 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	33 Participants n=5 Participants	21 Participants n=7 Participants	54 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic/Latino	118 Participants n=5 Participants	115 Participants n=7 Participants	233 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
ECOG Performance Status 0	39 Participants n=5 Participants	42 Participants n=7 Participants	81 Participants n=5 Participants
ECOG Performance Status 1	92 Participants n=5 Participants	82 Participants n=7 Participants	174 Participants n=5 Participants
ECOG Performance Status 2	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
ECOG Performance Status 3	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
ECOG Performance Status Missing	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: Cycle 7 Day 1 (each cycle was comprised of 4 weeks)

Population: Full Analysis Set (FAS): all participants to whom study treatment was assigned by randomization. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020).

ORR was defined as the percentage of participants in each arm demonstrating a complete response (CR) or partial response (PR) based on chronic GvHD (cGvHD) disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response. Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies.

Outcome measures

Measure	Ruxolitinib n=165 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy n=164 Participants Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit	49.7 percentage of participants Interval 41.8 to 57.6	25.6 percentage of participants Interval 19.1 to 33.0	—

SECONDARY outcome

Timeframe: Baseline; Cycle 7 Day 1 (each cycle was comprised of 4 weeks)

Population: FAS. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020).

To assess improvement of symptoms based on the total symptom score (TSS); a responder was defined as having achieved a clinically relevant reduction from Baseline of the TSS. The scale consists of 30 items in 7 subscales (skin, eye, mouth, lung, nutrition, energy, and psychological). Participants reported their level of symptom "bother" over the previous month on a 5-point likert scale: not at all, slightly, moderately, quite a bit, or extremely. Subscale scores and the summary score range from 0 to 100, with a higher score indicating worse symptoms.

Outcome measures

Measure	Ruxolitinib n=165 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy n=164 Participants Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
Rate of Participants With Clinically Relevant Improvement of the Modified Lee cGvHD Symptom Scale Score	24.2 percentage of participants Interval 17.9 to 31.5	11.0 percentage of participants Interval 6.6 to 16.8	—

SECONDARY outcome

Timeframe: Baseline to when the last participant reached Cycle 7 Day 1 (each cycle was comprised of 4 weeks)

Population: FAS. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020).

Composite time to event endpoint incorporating the following FFS events: (i) relapse or recurrence of underlying disease or death due to underlying disease, (ii) nonrelapse mortality, or (iii) addition or initiation of another systemic therapy for cGvHD.

Outcome measures

Measure	Ruxolitinib n=165 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy n=164 Participants Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
Rate of Failure-free Survival (FFS)	NA months Interval 18.6 to The median FFS time was not reached due to an insufficient number of participants with events.	5.7 months Interval 5.6 to 6.5	—

SECONDARY outcome

Timeframe: From Baseline to Last Participant Last Visit (LPLV) (approximately 5 years)

Population: FAS

Composite time to event endpoint incorporating the following FFS events: (i) relapse or recurrence of underlying disease or death due to underlying disease, (ii) nonrelapse mortality, or (iii) addition or initiation of another systemic therapy for cGvHD.

Outcome measures

Measure	Ruxolitinib n=165 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy n=164 Participants Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
Rate of FFS at Study Completion	38.4 months Interval 22.1 to The upper limit of the confidence interval was not estimable due to an insufficient number of participants with events.	5.7 months Interval 5.6 to 6.5	—

SECONDARY outcome

Timeframe: up to Cycle 7 Day 1 (each cycle was comprised of 4 weeks)

Population: FAS. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020).

BOR was defined as the percentage of participants who achieved an overall response (CR+PR) based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response at any time point (up to Cycle 7 Day 1 or the start of additional systemic therapy for cGvHD). Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies. This analysis was based on the primary cutoff date (May 2020).

Outcome measures

Measure	Ruxolitinib n=165 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy n=164 Participants Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
Best Overall Response (BOR) at Cycle 7 Day 1	76.4 percentage of participants Interval 69.1 to 82.6	60.4 percentage of participants Interval 52.4 to 67.9	—

SECONDARY outcome

Timeframe: from Crossover Cycle 1 Day 1 to any time point up to and including Crossover Cycle 7 Day 1 (each cycle was comprised of 4 weeks)

Population: Cross-over Analysis Set

BOR was defined as the percentage of participants who achieved an overall response (CR+PR) based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response at any time point (up to Cycle 7 Day 1 or the start of additional systemic therapy for cGvHD). Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies.

Outcome measures

Measure	Ruxolitinib n=70 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
BOR During Cross-over Treatment With Ruxolitinib	81.4 percentage of participants Interval 70.3 to 89.7	—	—

SECONDARY outcome

Timeframe: Cycle 4 Day 1 (each cycle was comprised of 4 weeks)

Population: FAS

ORR was defined as the percentage of participants in each arm demonstrating a CR or PR based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response. Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies.

Outcome measures

Measure	Ruxolitinib n=165 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy n=164 Participants Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
ORR at the End of Cycle 3	54.5 percentage of participants Interval 46.6 to 62.3	31.1 percentage of participants Interval 24.1 to 38.8	—

SECONDARY outcome

Timeframe: from first response to LPLV (approximately 5 years)

Population: FAS. Duration of response was evaluated in participants who achieved a CR or PR at or before Cycle 7 Day 1.

DOR was defined as the time from first response until cGvHD progression, death, or the date of change/addition of systemic therapies for cGvHD and as assessed for responders only. Response was based on cGvHD disease assessments (National Institutes of Health consensus criteria). Duration of response was evaluated in participants who achieved a CR or PR at or before Cycle 7 Day 1. The analysis included a larger number of participants than the number of participants who achieved CR or PR at Cycle 7 Day 1 (82 ruxolitinib and 42 BAT) because the analysis took into account not only those participants who achieved CR or PR at Cycle 7 Day 1, but also participants who achieved CR or PR before Cycle 7 Day 1 but who may have lost their response at Cycle 7 Day 1. For this reason, the number of participants in this analysis does not align with the best overall response (BOR) at Cycle 7 Day 1. This analysis was based on the cutoff date upon study completion (December 2022).

Outcome measures

Measure	Ruxolitinib n=126 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy n=103 Participants Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
Duration of Response Through Study Completion	NA Months Median duration of response was not reached due to an insufficient number of participants with events.	6.4 Months Interval 4.9 to 11.4	—

SECONDARY outcome

Timeframe: from the date of randomization to the date of death due to any cause up to LPLV (approximately 5 years)

Population: FAS

Overall survival was defined as the time from the date of randomization to the date of death due to any cause.

Outcome measures

Measure	Ruxolitinib n=165 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy n=164 Participants Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
Overall Survival (OS)	NA months The median and upper and lower limits of the confidence interval were not estimable because too few participants died.	NA months Interval 41.0 to The median and upper limit of the confidence interval were not estimable because too few participants died.	—

SECONDARY outcome

Timeframe: Months 3, 6, 12, 18, 24, 30, and 36

Population: FAS. Only participants with available data were analyzed.

Defined as the cumulative incidence rate from competing risk analysis for NRM from the date of randomization to the date of death not preceded by underlying disease relapse/recurrence.

Outcome measures

Measure	Ruxolitinib n=165 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy n=164 Participants Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
Cumulative Incidence of Non-relapse Mortality (NRM) Month 3	5.45 percentage of participants Interval 2.68 to 9.67	4.44 percentage of participants Interval 1.96 to 8.48	—
Cumulative Incidence of Non-relapse Mortality (NRM) Month 6	9.13 percentage of participants Interval 5.34 to 14.15	6.43 percentage of participants Interval 3.28 to 11.03	—
Cumulative Incidence of Non-relapse Mortality (NRM) Month 12	15.30 percentage of participants Interval 10.26 to 21.26	15.12 percentage of participants Interval 9.94 to 21.3	—
Cumulative Incidence of Non-relapse Mortality (NRM) Month 18	15.93 percentage of participants Interval 10.78 to 21.98	16.48 percentage of participants Interval 11.06 to 22.84	—
Cumulative Incidence of Non-relapse Mortality (NRM) Month 24	17.83 percentage of participants Interval 12.37 to 24.1	19.22 percentage of participants Interval 13.36 to 25.9	—
Cumulative Incidence of Non-relapse Mortality (NRM) Month 30	17.83 percentage of participants Interval 12.37 to 24.1	19.22 percentage of participants Interval 13.94 to 26.67	—
Cumulative Incidence of Non-relapse Mortality (NRM) Month 36	17.83 percentage of participants Interval 12.37 to 24.1	22.0 percentage of participants Interval 15.73 to 28.96	—

SECONDARY outcome

Timeframe: from Day 15 up to Day 182

Population: Safety Set: all participants who received at least one dose of study treatment. Participants were to have been analyzed according to the study treatment received, where treatment received was defined as the randomized treatment if the participant took at least one dose of that treatment or the first treatment received if the randomized treatment was never received. Six participants in the BAT arm discontinued before receiving the first dose. Only participants with available data were analyzed.

All corticosteroid dosages prescribed to the participant and all dose changes during the study were to be recorded for assessment of participants with a ≥ 50% reduction in daily corticosteroid dose.

Outcome measures

Measure	Ruxolitinib n=165 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy n=158 Participants Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
Percentage of Participants With a ≥ 50% Reduction in Daily Corticosteroid Dose Day 15 to ≤ Day 28	12.7 percentage of participants	13.2 percentage of participants	—
Percentage of Participants With a ≥ 50% Reduction in Daily Corticosteroid Dose Day 29 to ≤ Day 42	35.0 percentage of participants	33.1 percentage of participants	—
Percentage of Participants With a ≥ 50% Reduction in Daily Corticosteroid Dose Day 43 to ≤ Day 56	48.4 percentage of participants	41.1 percentage of participants	—
Percentage of Participants With a ≥ 50% Reduction in Daily Corticosteroid Dose Day 57 to ≤ Day 70	58.7 percentage of participants	47.9 percentage of participants	—
Percentage of Participants With a ≥ 50% Reduction in Daily Corticosteroid Dose Day 71 to ≤ Day 84	62.3 percentage of participants	51.4 percentage of participants	—
Percentage of Participants With a ≥ 50% Reduction in Daily Corticosteroid Dose Day 85 to ≤ Day 98	69.5 percentage of participants	54.0 percentage of participants	—
Percentage of Participants With a ≥ 50% Reduction in Daily Corticosteroid Dose Day 99 to ≤ Day 112	71.2 percentage of participants	60.4 percentage of participants	—
Percentage of Participants With a ≥ 50% Reduction in Daily Corticosteroid Dose Day 113 to ≤ Day 126	73.2 percentage of participants	66.2 percentage of participants	—
Percentage of Participants With a ≥ 50% Reduction in Daily Corticosteroid Dose Day 127 to ≤ Day 140	72.8 percentage of participants	68.3 percentage of participants	—
Percentage of Participants With a ≥ 50% Reduction in Daily Corticosteroid Dose Day 141 to ≤ Day 154	70.0 percentage of participants	68.3 percentage of participants	—
Percentage of Participants With a ≥ 50% Reduction in Daily Corticosteroid Dose Day 155 to ≤ Day 168	74.6 percentage of participants	71.6 percentage of participants	—
Percentage of Participants With a ≥ 50% Reduction in Daily Corticosteroid Dose Day 169 to ≤ Day 182	81.9 percentage of participants	88.8 percentage of participants	—

SECONDARY outcome

Timeframe: up to Day 179

Population: FAS. Only participants with available data were analyzed.

All corticosteroid dosages prescribed to the participant and all dose changes during the study were to be recorded for assessment of participants who successfully tapered off of all corticosteroids. Participants who completely tapered off corticosteroids refer to those who permanently discontinued steroids as per the dose administration panel and who did not restart steroids in the same interval. Participants who were tapered off and continued follow-up were also counted as being tapered off with 0 dose in subsequent intervals until they discontinued from the main treatment period or restarted steroid treatment.

Outcome measures

Measure	Ruxolitinib n=165 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy n=158 Participants Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
Percentage of Participants Successfully Tapered Off of All Corticosteroids Day 1 to ≤ Day 28	2.5 percentage of participants	2.6 percentage of participants	—
Percentage of Participants Successfully Tapered Off of All Corticosteroids Day 29 to ≤ Day 56	9.6 percentage of participants	5.4 percentage of participants	—
Percentage of Participants Successfully Tapered Off of All Corticosteroids Day 57 to ≤ Day 84	14.0 percentage of participants	8.5 percentage of participants	—
Percentage of Participants Successfully Tapered Off of All Corticosteroids Day 85 to ≤ Day 112	16.3 percentage of participants	10.3 percentage of participants	—
Percentage of Participants Successfully Tapered Off of All Corticosteroids Day 113 to ≤ Day 140	19.7 percentage of participants	12.4 percentage of participants	—
Percentage of Participants Successfully Tapered Off of All Corticosteroids Day 141 to ≤ Day 168	24.2 percentage of participants	16.8 percentage of participants	—
Percentage of Participants Successfully Tapered Off of All Corticosteroids Day 169 to ≤ Day 179	24.1 percentage of participants	15.9 percentage of participants	—

SECONDARY outcome

Timeframe: Months 3, 6, 12, 18, 24, 30, and 36

Population: FAS. Cumulative incidence was calculated for participants with underlying hematologic malignant disease. Only participants with available data were analyzed.

Defined as the cumulative incidence rate from competing risk analysis of MR from the date of randomization to hematologic malignancy relapse/recurrence.

Outcome measures

Measure	Ruxolitinib n=156 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy n=160 Participants Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
Cumulative Incidence of Malignancy Relapse/Recurrence (MR) 24 to <30 months	8.48 percentage of participants Interval 4.74 to 13.57	6.78 percentage of participants Interval 3.46 to 11.62	—
Cumulative Incidence of Malignancy Relapse/Recurrence (MR) 0 to < 3 months	1.92 percentage of participants Interval 0.52 to 5.12	1.31 percentage of participants Interval 0.26 to 4.27	—
Cumulative Incidence of Malignancy Relapse/Recurrence (MR) 3 to < 6 months	3.22 percentage of participants Interval 1.2 to 6.93	2.65 percentage of participants Interval 0.87 to 6.21	—
Cumulative Incidence of Malignancy Relapse/Recurrence (MR) 6 to < 12 months	5.18 percentage of participants Interval 2.42 to 9.49	6.08 percentage of participants Interval 2.98 to 10.73	—
Cumulative Incidence of Malignancy Relapse/Recurrence (MR) 12 to < 18 months	7.82 percentage of participants Interval 4.25 to 12.77	6.08 percentage of participants Interval 2.98 to 10.73	—
Cumulative Incidence of Malignancy Relapse/Recurrence (MR) 18 to < 24 months	8.48 percentage of participants Interval 4.74 to 13.57	6.08 percentage of participants Interval 2.98 to 10.73	—
Cumulative Incidence of Malignancy Relapse/Recurrence (MR) 30 to <36 months	8.48 percentage of participants Interval 4.74 to 13.57	7.50 percentage of participants Interval 3.96 to 12.52	—

SECONDARY outcome

Timeframe: Baseline; up to Cycle 39 Day 1 (each cycle was comprised of 4 weeks)

Population: FAS. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The FACT-BMT is a 50-item self-report questionnaire that measures the effect of a therapy on domains including physical, functional, social/family, and emotional well-being, together with additional concerns relevant for bone marrow transplantation participants. The questions were based on a 5-point Likert scale, where 0 corresponds to "not at all" and 4 corresponds to "very much." The higher the final score, the better the quality of life. The FACT-BMT total score ranges from 0 to 148.

Outcome measures

Measure	Ruxolitinib n=165 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy n=164 Participants Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) Cycle 2 Day 1	2.32 scores on a scale Standard Deviation 12.191	-0.22 scores on a scale Standard Deviation 14.949	—
Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) Cycle 3 Day 1	0.62 scores on a scale Standard Deviation 14.452	-1.82 scores on a scale Standard Deviation 15.849	—
Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) Cycle 4 Day 1	1.98 scores on a scale Standard Deviation 15.888	-1.05 scores on a scale Standard Deviation 16.147	—
Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) Cycle 5 Day 1	1.25 scores on a scale Standard Deviation 14.577	-0.23 scores on a scale Standard Deviation 18.903	—
Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) Cycle 6 Day 1	2.91 scores on a scale Standard Deviation 14.562	2.41 scores on a scale Standard Deviation 14.766	—
Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) Cycle 7 Day 1	4.14 scores on a scale Standard Deviation 14.669	0.85 scores on a scale Standard Deviation 16.811	—
Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) Cycle 9 Day 1	5.32 scores on a scale Standard Deviation 16.815	1.20 scores on a scale Standard Deviation 17.635	—
Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) Cycle 12 Day 1	7.26 scores on a scale Standard Deviation 19.296	3.74 scores on a scale Standard Deviation 18.059	—
Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) Cycle 15 Day 1	5.07 scores on a scale Standard Deviation 18.220	7.58 scores on a scale Standard Deviation 17.063	—
Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) Cycle 18 Day 1	4.10 scores on a scale Standard Deviation 19.440	8.19 scores on a scale Standard Deviation 17.993	—
Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) Cycle 21 Day 1	5.24 scores on a scale Standard Deviation 19.485	3.68 scores on a scale Standard Deviation 17.378	—
Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) Cycle 24 Day 1	5.90 scores on a scale Standard Deviation 19.662	7.84 scores on a scale Standard Deviation 18.561	—
Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) Cycle 27 Day 1	6.23 scores on a scale Standard Deviation 18.880	5.10 scores on a scale Standard Deviation 18.885	—
Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) Cycle 30 Day 1	7.53 scores on a scale Standard Deviation 20.314	5.75 scores on a scale Standard Deviation 21.037	—
Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) Cycle 33 Day 1	5.17 scores on a scale Standard Deviation 20.330	5.67 scores on a scale Standard Deviation 22.573	—
Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) Cycle 36 Day 1	8.72 scores on a scale Standard Deviation 18.710	4.77 scores on a scale Standard Deviation 24.186	—
Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) Cycle 39 Day 1	8.65 scores on a scale Standard Deviation 21.669	6.64 scores on a scale Standard Deviation 22.384	—

SECONDARY outcome

Timeframe: Baseline; up to Cycle 39 Day 1 (each cycle was comprised of 4 weeks)

Population: FAS. Only participants with available data were analyzed.

The EQ-5D-5L is a descriptive classification consisting of five dimensions of health: mobility, self-care, usual activities, anxiety/depression, and pain/discomfort. The five-level version (no problems, slight problems, moderate problems, severe problems, and extreme problems) uses a 5-point Likert scale, with 1 being no problems and 5 being extreme problems.

Outcome measures

Measure	Ruxolitinib n=165 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy n=164 Participants Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
Change From Baseline in EQ-5D-5L Cycle 2 Day 1	0.03 scores on a scale Standard Deviation 0.214	-0.01 scores on a scale Standard Deviation 0.163	—
Change From Baseline in EQ-5D-5L Cycle 3 Day 1	0.03 scores on a scale Standard Deviation 0.221	-0.04 scores on a scale Standard Deviation 0.259	—
Change From Baseline in EQ-5D-5L Cycle 4 Day 1	0.04 scores on a scale Standard Deviation 0.196	-0.01 scores on a scale Standard Deviation 0.192	—
Change From Baseline in EQ-5D-5L Cycle 5 Day 1	0.02 scores on a scale Standard Deviation 0.210	-0.03 scores on a scale Standard Deviation 0.243	—
Change From Baseline in EQ-5D-5L Cycle 6 Day 1	0.05 scores on a scale Standard Deviation 0.230	0.01 scores on a scale Standard Deviation 0.186	—
Change From Baseline in EQ-5D-5L Cycle 7 Day 1	0.07 scores on a scale Standard Deviation 0.234	-0.00 scores on a scale Standard Deviation 0.225	—
Change From Baseline in EQ-5D-5L Cycle 9 Day 1	0.07 scores on a scale Standard Deviation 0.228	-0.02 scores on a scale Standard Deviation 0.166	—
Change From Baseline in EQ-5D-5L Cycle 12 Day 1	0.07 scores on a scale Standard Deviation 0.187	0.02 scores on a scale Standard Deviation 0.158	—
Change From Baseline in EQ-5D-5L Cycle 15 Day 1	0.07 scores on a scale Standard Deviation 0.250	0.03 scores on a scale Standard Deviation 0.140	—
Change From Baseline in EQ-5D-5L Cycle 18 Day 1	0.07 scores on a scale Standard Deviation 0.299	0.02 scores on a scale Standard Deviation 0.110	—
Change From Baseline in EQ-5D-5L Cycle 21 Day 1	0.08 scores on a scale Standard Deviation 0.268	-0.00 scores on a scale Standard Deviation 0.222	—
Change From Baseline in EQ-5D-5L Cycle 24 Day 1	0.07 scores on a scale Standard Deviation 0.272	0.01 scores on a scale Standard Deviation 0.164	—
Change From Baseline in EQ-5D-5L Cycle 27 Day 1	0.06 scores on a scale Standard Deviation 0.299	0.03 scores on a scale Standard Deviation 0.182	—
Change From Baseline in EQ-5D-5L Cycle 30 Day 1	0.05 scores on a scale Standard Deviation 0.261	0.01 scores on a scale Standard Deviation 0.159	—
Change From Baseline in EQ-5D-5L Cycle 33 Day 1	0.00 scores on a scale Standard Deviation 0.282	0.05 scores on a scale Standard Deviation 0.186	—
Change From Baseline in EQ-5D-5L Cycle 36 Day 1	0.06 scores on a scale Standard Deviation 0.231	0.04 scores on a scale Standard Deviation 0.216	—
Change From Baseline in EQ-5D-5L Cycle 39 Day 1	0.06 scores on a scale Standard Deviation 0.255	0.01 scores on a scale Standard Deviation 0.214	—

SECONDARY outcome

Timeframe: from Baseline to LPLV (approximately 5 years)

Population: Safety Set. Six participants in the BAT arm discontinued before receiving the first dose.

Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions that occurred after the participant's signed informed consent was obtained. Abnormal laboratory values or test results occurring after informed consent constituted adverse events only if they induced clinical signs or symptoms, were considered clinically significant, required therapy (e.g., hematologic abnormality that required transfusion or hematological stem cell support), or required changes in study medication(s). TEAEs were defined as those AEs that started or worsened during the on-treatment period (either randomized or cross-over period).

Outcome measures

Measure	Ruxolitinib n=165 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy n=158 Participants Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period n=70 Participants Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	165 Participants	148 Participants	70 Participants

SECONDARY outcome

Timeframe: Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose

Population: Pharmacokinetic Analysis Set (PAS): all participants who provided at least one evaluable pharmacokinetic (PK) concentration. Only participants with available data were analyzed.

Cmax was defined as the maximum observed plasma concentration of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.

Outcome measures

Measure	Ruxolitinib n=20 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
Cmax of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses Day 1	167 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 39.3	—	—
Cmax of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses Day 15	215 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 48.8	—	—

SECONDARY outcome

Timeframe: Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose

Population: PAS. Only participants with available data were analyzed.

AUClast was defined as the area under the concentration-time curve up to the last measurable concentration of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.

Outcome measures

Measure	Ruxolitinib n=20 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
AUClast of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses Day 1	636 ng*hour/mL Geometric Coefficient of Variation 40.8	—	—
AUClast of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses Day 15	945 ng*hour/mL Geometric Coefficient of Variation 56.1	—	—

SECONDARY outcome

Timeframe: Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose

Population: PAS. Only participants with available data were analyzed.

AUCinf was defined as the area under the concentration-time curve from time 0 to infinity. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.

Outcome measures

Measure	Ruxolitinib n=10 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
AUCinf of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses Day 1	642 ng*hour/mL Geometric Coefficient of Variation 32.7	—	—

SECONDARY outcome

Timeframe: Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose

Population: PAS. Only participants with available data were analyzed.

CL/F was defined as the oral dose clearance of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.

Outcome measures

Measure	Ruxolitinib n=20 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
CL/F of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses Day 1	15.6 Liters/hour Geometric Coefficient of Variation 32.7	—	—
CL/F of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses Day 15	15.2 Liters/hour Geometric Coefficient of Variation 20.4	—	—

SECONDARY outcome

Timeframe: Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose

Population: PAS. Only participants with available data were analyzed.

Vz/F was defined as the apparent oral dose volume of distribution of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.

Outcome measures

Measure	Ruxolitinib n=20 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
Vz/F of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses Day 1	54.0 Liters Geometric Coefficient of Variation 25.0	—	—
Vz/F of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses Day 15	50.9 Liters Geometric Coefficient of Variation 33.9	—	—

SECONDARY outcome

Timeframe: Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose

Population: PAS. Only participants with available data were analyzed.

tmax was defined as the time to reach the maximum plasma concentration of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.

Outcome measures

Measure	Ruxolitinib n=20 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
Tmax of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses Day 1	0.833 hours Interval 0.417 to 4.08	—	—
Tmax of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses Day 15	1.00 hours Interval 0.417 to 2.0	—	—

SECONDARY outcome

Timeframe: Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose

Population: PAS. Only participants with available data were analyzed.

t1/2 was defined as the apparent terminal phase disposition half-life of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.

Outcome measures

Measure	Ruxolitinib n=20 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
t1/2 of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses Day 1	2.40 hours Geometric Coefficient of Variation 28.9	—	—
t1/2 of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses Day 15	2.32 hours Geometric Coefficient of Variation 19.8	—	—

SECONDARY outcome

Timeframe: from Baseline to LPLV (approximately 5 years)

Population: Safety Set. Six participants in the BAT arm discontinued before receiving the first dose.

The percentage of participants with at least one submission to healthcare encounter was assessed.

Outcome measures

Measure	Ruxolitinib n=165 Participants Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy n=158 Participants Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
Utilization of Medical Resources	57.0 percentage of participants	65.8 percentage of participants	—

Adverse Events

Ruxolitinib

Serious events: 86 serious events

Other events: 158 other events

Deaths: 37 deaths

Best Available Therapy

Serious events: 71 serious events

Other events: 132 other events

Deaths: 40 deaths

Ruxolitinib Cross-Over Period

Serious events: 27 serious events

Other events: 62 other events

Deaths: 10 deaths

Serious adverse events

Measure	Ruxolitinib n=165 participants at risk Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy n=158 participants at risk Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period n=70 participants at risk Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Blood and lymphatic system disorders Anaemia	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	4.3% 3/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Blood and lymphatic system disorders Atypical haemolytic uraemic syndrome	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Blood and lymphatic system disorders Febrile neutropenia	2.4% 4/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.3% 2/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Blood and lymphatic system disorders Leukopenia	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Blood and lymphatic system disorders Neutropenia	1.2% 2/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.3% 2/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Blood and lymphatic system disorders Spleen disorder	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Blood and lymphatic system disorders Splenic haemorrhage	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Blood and lymphatic system disorders Thrombotic microangiopathy	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Cardiac disorders Acute myocardial infarction	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Cardiac disorders Aortic valve incompetence	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Cardiac disorders Atrial flutter	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Cardiac disorders Cardiac arrest	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Cardiac disorders Cardiac failure	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Cardiac disorders Cardiac failure congestive	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Cardiac disorders Cardiogenic shock	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Cardiac disorders Myocardial infarction	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Cardiac disorders Pericardial effusion	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Cardiac disorders Pericarditis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Cardiac disorders Tachycardia	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Endocrine disorders Adrenal insufficiency	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Eye disorders Angle closure glaucoma	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Eye disorders Corneal erosion	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Eye disorders Corneal perforation	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Eye disorders Keratitis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Eye disorders Ulcerative keratitis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	2.9% 2/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Abdominal pain	1.8% 3/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Anal fistula	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Diarrhoea	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.9% 3/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Enterocolitis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Gastritis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.9% 3/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Gastrointestinal ulcer	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Haematemesis	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Ileus	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Large intestine perforation	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Melaena	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Nausea	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Odynophagia	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Oesophagitis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Oral dysaesthesia	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Pancreatitis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Pancreatitis acute	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Pneumatosis intestinalis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Stomatitis	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Vomiting	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.3% 2/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
General disorders Asthenia	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
General disorders Catheter site haemorrhage	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
General disorders Catheter site pain	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
General disorders Fatigue	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
General disorders General physical health deterioration	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.3% 2/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
General disorders Generalised oedema	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
General disorders Hyperthermia	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
General disorders Multiple organ dysfunction syndrome	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
General disorders Necrosis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
General disorders Oedema peripheral	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
General disorders Pyrexia	6.7% 11/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	4.4% 7/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	4.3% 3/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
General disorders Stenosis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Hepatobiliary disorders Cholelithiasis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Abdominal wall infection	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Abscess limb	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Adenovirus reactivation	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Anal abscess	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Arthritis bacterial	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Aspergillus infection	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Bacteraemia	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Bacterial sepsis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Bacterial translocation	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Brain abscess	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Bronchitis	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Bronchopulmonary aspergillosis	1.8% 3/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	2.5% 4/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations COVID-19	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.3% 2/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations COVID-19 pneumonia	1.8% 3/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Clostridium difficile infection	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Cytomegalovirus infection	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Cytomegalovirus infection reactivation	1.2% 2/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Dacryocanaliculitis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Device related sepsis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Enterococcal infection	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Enterocolitis infectious	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Erysipelas	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Escherichia bacteraemia	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Escherichia infection	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.3% 2/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Escherichia sepsis	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Febrile infection	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Fungal infection	1.2% 2/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Gastroenteritis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Gastroenteritis viral	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Herpes zoster	2.4% 4/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Influenza	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Large intestine infection	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Liver abscess	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Lower respiratory tract infection	3.0% 5/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Lower respiratory tract infection fungal	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Measles	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Meningitis cryptococcal	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Meningitis viral	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Metapneumovirus infection	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Mycobacterial infection	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Oral candidiasis	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Oral herpes	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Pharyngitis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Pneumococcal infection	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Pneumocystis jirovecii pneumonia	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Pneumonia	14.5% 24/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	11.4% 18/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	7.1% 5/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Pneumonia bacterial	1.8% 3/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.3% 2/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Pneumonia cytomegaloviral	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.3% 2/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Pneumonia klebsiella	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Pneumonia pseudomonal	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.3% 2/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Pneumonia viral	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Pseudomonal sepsis	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Pulmonary nocardiosis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Pyelonephritis	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Respiratory syncytial virus infection	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Respiratory tract infection	1.2% 2/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	4.3% 3/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Respiratory tract infection bacterial	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Respiratory tract infection fungal	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Respiratory tract infection viral	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Sepsis	2.4% 4/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Septic shock	1.2% 2/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	2.5% 4/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Sinusitis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Skin infection	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Systemic infection	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Systemic mycosis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Tracheitis	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Upper respiratory tract infection	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.3% 2/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	2.9% 2/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Urinary tract infection	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Urosepsis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Wound infection	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Injury, poisoning and procedural complications Anastomotic complication	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Injury, poisoning and procedural complications Fall	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Injury, poisoning and procedural complications Infusion related reaction	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Injury, poisoning and procedural complications Spinal compression fracture	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Investigations Alanine aminotransferase increased	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Investigations Blood creatinine increased	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Investigations Cytomegalovirus test positive	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Investigations Gamma-glutamyltransferase increased	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Investigations Platelet count decreased	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Investigations SARS-CoV-2 test positive	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Investigations White blood cell count decreased	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Metabolism and nutrition disorders Decreased appetite	1.2% 2/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Metabolism and nutrition disorders Dehydration	1.2% 2/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Metabolism and nutrition disorders Hypokalaemia	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Musculoskeletal and connective tissue disorders Back pain	1.2% 2/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Musculoskeletal and connective tissue disorders Muscular weakness	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Musculoskeletal and connective tissue disorders Osteonecrosis	2.4% 4/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.3% 2/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Musculoskeletal and connective tissue disorders Pain in extremity	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Musculoskeletal and connective tissue disorders Tendon disorder	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kaposi's sarcoma	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Post transplant lymphoproliferative disorder	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin squamous cell carcinoma recurrent	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Nervous system disorders Depressed level of consciousness	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Nervous system disorders Encephalopathy	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Nervous system disorders Epilepsy	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Nervous system disorders Haemorrhage intracranial	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Nervous system disorders Headache	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Nervous system disorders Intracranial pressure increased	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Nervous system disorders Metabolic encephalopathy	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Nervous system disorders Neuralgia	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Nervous system disorders Neuropathy peripheral	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Nervous system disorders Seizure	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.3% 2/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Nervous system disorders Somnolence	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Nervous system disorders Spinal cord compression	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Nervous system disorders Syncope	1.2% 2/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Nervous system disorders Transient ischaemic attack	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Product Issues Device breakage	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Psychiatric disorders Agitation	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Psychiatric disorders Completed suicide	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Psychiatric disorders Confusional state	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Psychiatric disorders Depression	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Renal and urinary disorders Acute kidney injury	1.2% 2/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.9% 3/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Renal and urinary disorders Haematuria	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Renal and urinary disorders Nephrolithiasis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.3% 2/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Renal and urinary disorders Renal impairment	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Renal and urinary disorders Urinary retention	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Reproductive system and breast disorders Vulvovaginal inflammation	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Alveolar proteinosis	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Cough	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.8% 3/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.9% 3/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	2.9% 2/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.2% 2/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.9% 3/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Obliterative bronchiolitis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.2% 2/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.8% 3/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.8% 3/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.9% 3/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.2% 2/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.3% 2/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Skin and subcutaneous tissue disorders Toxic epidermal necrolysis	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Social circumstances Loss of personal independence in daily activities	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Vascular disorders Deep vein thrombosis	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Vascular disorders Hypertension	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Vascular disorders Hypotension	1.2% 2/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Vascular disorders Poor peripheral circulation	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Vascular disorders Vena cava thrombosis	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Vascular disorders Venous thrombosis limb	0.00% 0/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.

Other adverse events

Measure	Ruxolitinib n=165 participants at risk Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).	Best Available Therapy n=158 participants at risk Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.	Ruxolitinib Cross-Over Period n=70 participants at risk Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
Blood and lymphatic system disorders Anaemia	33.9% 56/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	15.8% 25/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	21.4% 15/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Blood and lymphatic system disorders Leukopenia	6.1% 10/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.3% 2/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Blood and lymphatic system disorders Neutropenia	15.2% 25/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	5.1% 8/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	11.4% 8/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Blood and lymphatic system disorders Thrombocytopenia	12.7% 21/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	8.9% 14/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	10.0% 7/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Eye disorders Cataract	2.4% 4/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	3.8% 6/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	7.1% 5/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Eye disorders Dry eye	6.7% 11/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	6.3% 10/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	2.9% 2/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Abdominal pain	4.2% 7/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	5.7% 9/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	5.7% 4/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Constipation	8.5% 14/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	6.3% 10/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	7.1% 5/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Diarrhoea	16.4% 27/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	14.6% 23/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	8.6% 6/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Dyspepsia	2.4% 4/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	2.5% 4/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	5.7% 4/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Nausea	11.5% 19/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	13.3% 21/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	4.3% 3/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Gastrointestinal disorders Vomiting	9.1% 15/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	7.6% 12/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	4.3% 3/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
General disorders Asthenia	2.4% 4/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	2.5% 4/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	7.1% 5/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
General disorders Fatigue	15.2% 25/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	9.5% 15/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	10.0% 7/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
General disorders Oedema peripheral	7.9% 13/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	11.4% 18/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	5.7% 4/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
General disorders Pyrexia	20.6% 34/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	10.1% 16/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	12.9% 9/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations BK virus infection	5.5% 9/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.3% 2/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	4.3% 3/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Bronchitis	4.2% 7/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.9% 3/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	10.0% 7/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations COVID-19	4.8% 8/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	7.1% 5/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Conjunctivitis	7.9% 13/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	3.8% 6/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	2.9% 2/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Cytomegalovirus infection reactivation	4.8% 8/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	9.5% 15/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	5.7% 4/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Influenza	9.7% 16/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	6.3% 10/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	2.9% 2/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Nasopharyngitis	10.3% 17/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	6.3% 10/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Pneumonia	4.8% 8/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	7.0% 11/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	8.6% 6/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Upper respiratory tract infection	11.5% 19/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	9.5% 15/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	17.1% 12/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Infections and infestations Urinary tract infection	7.9% 13/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	5.7% 9/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	5.7% 4/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Investigations Alanine aminotransferase increased	19.4% 32/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	5.1% 8/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	7.1% 5/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Investigations Amylase increased	7.3% 12/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	2.5% 4/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	2.9% 2/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Investigations Aspartate aminotransferase increased	11.5% 19/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	3.8% 6/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	4.3% 3/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Investigations Blood alkaline phosphatase increased	7.3% 12/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	3.8% 6/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	4.3% 3/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Investigations Blood cholesterol increased	9.1% 15/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	4.4% 7/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Investigations Blood creatine phosphokinase increased	6.7% 11/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	2.9% 2/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Investigations Blood creatinine increased	17.6% 29/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	5.1% 8/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	5.7% 4/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Investigations Fibrin D dimer increased	5.5% 9/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Investigations Gamma-glutamyltransferase increased	11.5% 19/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	4.4% 7/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	4.3% 3/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Investigations Lipase increased	6.1% 10/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	2.5% 4/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	4.3% 3/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Investigations Platelet count decreased	11.5% 19/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	7.0% 11/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Metabolism and nutrition disorders Hypercholesterolaemia	7.9% 13/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.3% 2/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	11.4% 8/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Metabolism and nutrition disorders Hyperglycaemia	7.9% 13/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	3.8% 6/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Metabolism and nutrition disorders Hyperkalaemia	7.3% 12/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	2.5% 4/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	7.1% 5/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Metabolism and nutrition disorders Hypertriglyceridaemia	9.7% 16/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	8.9% 14/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	5.7% 4/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Metabolism and nutrition disorders Hyperuricaemia	5.5% 9/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.63% 1/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	2.9% 2/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Metabolism and nutrition disorders Hypokalaemia	9.1% 15/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	13.9% 22/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	2.9% 2/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Metabolism and nutrition disorders Hypomagnesaemia	4.8% 8/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	7.0% 11/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	2.9% 2/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Metabolism and nutrition disorders Hypophosphataemia	2.4% 4/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	5.1% 8/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	5.7% 4/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Musculoskeletal and connective tissue disorders Arthralgia	12.1% 20/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	8.2% 13/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	10.0% 7/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Musculoskeletal and connective tissue disorders Back pain	10.9% 18/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	6.3% 10/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	7.1% 5/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Musculoskeletal and connective tissue disorders Myalgia	10.3% 17/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	4.4% 7/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Musculoskeletal and connective tissue disorders Pain in extremity	6.1% 10/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	3.2% 5/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Nervous system disorders Headache	10.3% 17/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	8.9% 14/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	8.6% 6/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Nervous system disorders Tremor	4.2% 7/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	5.1% 8/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Psychiatric disorders Insomnia	7.9% 13/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	5.1% 8/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Cough	15.2% 25/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	9.5% 15/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	17.1% 12/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.5% 19/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	6.3% 10/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	7.1% 5/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	4.8% 8/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	5.1% 8/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	0.00% 0/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Skin and subcutaneous tissue disorders Pruritus	0.61% 1/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	5.1% 8/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	1.4% 1/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
Vascular disorders Hypertension	20.0% 33/165 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	13.3% 21/158 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.	10.0% 7/70 • from Baseline to LPLV (approximately 5 years) Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.

Additional Information

Incyte Corporation

Call Center

Phone: 1.855.463.3463

Email: medinfo@incyte.com

Results disclosure agreements

• Principal investigator is a sponsor employee Clinical Study Agreement
• Publication restrictions are in place

Restriction type: OTHER