Trial Outcomes & Findings for A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease (NCT NCT04540497)

NCT ID: NCT04540497

Last Updated: 2025-12-11

Results Overview

Time to disease flare was defined as the number of days from Day 1 (dosing) to the date of the first treated and Adjudication Committee (AC)-determined IgG4-RD flare within the 52-week RCP. The date of disease flare was determined by the initiation of any flare treatment, including new or increased glucocorticoid (GC) treatment, other immunotherapy, or an interventional procedure, as deemed necessary by the Investigator to address the flare. Kaplan-Meier (KM) method was used to estimate the median time to flare, and 95% confidence interval (CI).

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 135 participants
• Primary outcome timeframe: Up to Week 52
• Results posted on: 2025-12-11

Participant Flow

Participants affected by immunoglobulin G4-related disease (IgG4-RD) were recruited across 46 sites in Argentina, Australia, Canada, China, France, Germany, Israel, Italy, Japan, Mexico, Netherlands, Poland, Spain, Turkey, the United Kingdom and the United States, between December 2020 and February 2024 which was the safety data cutoff date.

After a 28-day screening period, participants entered a 52-week randomized controlled period (RCP), followed by an optional 3-year open-label period (OLP). The study also included a 2-year safety follow-up (SFUP). The study is ongoing; efficacy data covers the 52-week RCP, while safety data, including 90 participants, were collected up to the cut-off date in February 2024.

Participant milestones

Measure	RCP: Placebo/OLP: Inebilizumab 300 mg Participants with IgG4-RD were randomized to receive placebo intravenous (IV) infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation. After completing the RCP, participants had the option to enter the optional 3-year OLP, where they received inebilizumab on OLP Days 1 and 15. Participants then received inebilizumab every 6 months (Q6M) for the duration of the OLP.	RCP: Inebilizumab 300 mg/OLP: Inebilizumab 300 mg Participants with IgG4-RD were randomized to receive inebilizumab 300 mg IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation. After completing the RCP, participants had the option to enter the optional 3-year OLP, where they received inebilizumab on OLP Day 1 and matching placebo on Day 15. Participants then received inebilizumab Q6M for the duration of the OLP.
Overall Study STARTED	67	68
Overall Study Started Optional OLP	49	53
Overall Study COMPLETED	63	64
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Measure	RCP: Placebo/OLP: Inebilizumab 300 mg Participants with IgG4-RD were randomized to receive placebo intravenous (IV) infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation. After completing the RCP, participants had the option to enter the optional 3-year OLP, where they received inebilizumab on OLP Days 1 and 15. Participants then received inebilizumab every 6 months (Q6M) for the duration of the OLP.	RCP: Inebilizumab 300 mg/OLP: Inebilizumab 300 mg Participants with IgG4-RD were randomized to receive inebilizumab 300 mg IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation. After completing the RCP, participants had the option to enter the optional 3-year OLP, where they received inebilizumab on OLP Day 1 and matching placebo on Day 15. Participants then received inebilizumab Q6M for the duration of the OLP.
Overall Study Adverse Event	0	2
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	1	1
Overall Study Miscellaneous	2	1

Baseline Characteristics

A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease

Baseline characteristics by cohort

Measure	Placebo n=67 Participants Participants with IgG4-RD were randomized to receive placebo IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation. After completing the RCP, participants had the option to enter the optional 3-year OLP, where they received inebilizumab on OLP Days 1 and 15. Participants then received inebilizumab every 6 months (Q6M) for the duration of the OLP.	Inebilizumab 300 mg n=68 Participants Participants with IgG4-RD were randomized to receive inebilizumab 300 mg IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation.	Total n=135 Participants Total of all reporting groups
Age, Continuous	58.2 Years STANDARD_DEVIATION 12.2 • n=237 Participants	58.2 Years STANDARD_DEVIATION 11.5 • n=243 Participants	58.2 Years STANDARD_DEVIATION 11.8 • n=480 Participants
Sex: Female, Male Female	18 Participants n=237 Participants	29 Participants n=243 Participants	47 Participants n=480 Participants
Sex: Female, Male Male	49 Participants n=237 Participants	39 Participants n=243 Participants	88 Participants n=480 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=237 Participants	8 Participants n=243 Participants	16 Participants n=480 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=237 Participants	56 Participants n=243 Participants	109 Participants n=480 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=237 Participants	4 Participants n=243 Participants	10 Participants n=480 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=237 Participants	2 Participants n=243 Participants	2 Participants n=480 Participants
Race/Ethnicity, Customized Asian	25 Participants n=237 Participants	38 Participants n=243 Participants	63 Participants n=480 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=237 Participants	0 Participants n=243 Participants	1 Participants n=480 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=237 Participants	1 Participants n=243 Participants	1 Participants n=480 Participants
Race/Ethnicity, Customized White	32 Participants n=237 Participants	21 Participants n=243 Participants	53 Participants n=480 Participants
Race/Ethnicity, Customized Other	2 Participants n=237 Participants	2 Participants n=243 Participants	4 Participants n=480 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=237 Participants	0 Participants n=243 Participants	1 Participants n=480 Participants
Race/Ethnicity, Customized Not Reported	6 Participants n=237 Participants	4 Participants n=243 Participants	10 Participants n=480 Participants

PRIMARY outcome

Timeframe: Up to Week 52

Population: Full Analysis Set: all participants who received any dose of investigational product during the RCP.

Time to disease flare was defined as the number of days from Day 1 (dosing) to the date of the first treated and Adjudication Committee (AC)-determined IgG4-RD flare within the 52-week RCP. The date of disease flare was determined by the initiation of any flare treatment, including new or increased glucocorticoid (GC) treatment, other immunotherapy, or an interventional procedure, as deemed necessary by the Investigator to address the flare.

Kaplan-Meier (KM) method was used to estimate the median time to flare, and 95% confidence interval (CI).

Outcome measures

Measure	Placebo n=67 Participants Participants with IgG4-RD were randomized to receive placebo IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation.	Inebilizumab 300 mg n=68 Participants Participants with IgG4-RD were randomized to receive inebilizumab 300 mg IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation.
RCP: Time to Disease Flare	246.0 Days Interval 191.0 to Due to the low level of events of disease flare, the upper limit of the CI could not be calculated using the KM method.	NA Days Interval 371.0 to Due to the low level of events of disease flare, the median time to disease flare, and the upper limit of the CI could not be calculated using the KM method.

SECONDARY outcome

Timeframe: Week 52

Population: Full Analysis Set: all participants who received any dose of investigational product during the RCP.

The annualized rate of treated and AC-determined flares during the 52-week RCP was calculated by dividing the total number of treated and AC-determined flares by the total time at risk (in years) for all participants. This measure reflected the frequency of disease flares per person per year during the RCP.

Outcome measures

Measure	Placebo n=67 Participants Participants with IgG4-RD were randomized to receive placebo IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation.	Inebilizumab 300 mg n=68 Participants Participants with IgG4-RD were randomized to receive inebilizumab 300 mg IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation.
RCP: Annualized Rate of Treated and AC-Determined Flares During the RCP	0.71 Flares per person per year Interval 0.53 to 0.94	0.10 Flares per person per year Interval 0.05 to 0.21

SECONDARY outcome

Timeframe: Week 52

Population: Full Analysis Set: all participants who received any dose of investigational product during the RCP.

Flare-free, treatment-free complete remission at Week 52 was defined as the absence of evident disease activity at Week 52, no AC-determined flare during the RCP, and no treatment for flare or disease control, except for the required 8-week glucocorticoid taper. Lack of evident disease activity was determined by either a score of 0 on the IgG4-RD Responder Index (score range: 0-4, with lower scores indicating better disease control) or an investigator's assessment that no disease activity was present based on physical, laboratory, pathology, or other evidence.

Outcome measures

Measure	Placebo n=67 Participants Participants with IgG4-RD were randomized to receive placebo IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation.	Inebilizumab 300 mg n=68 Participants Participants with IgG4-RD were randomized to receive inebilizumab 300 mg IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation.
RCP: Percentage of Participants Achieving Flare-free, Treatment-free Complete Remission at Week 52	15 Participants	39 Participants

SECONDARY outcome

Timeframe: Week 52

Population: Full Analysis Set: all participants who received any dose of investigational product during the RCP.

Flare-free, corticosteroid-free complete remission at Week 52 was defined as the absence of evident disease activity at Week 52, no AC-determined flare during the RCP, and no corticosteroid treatment for flare or disease control, except for the required 8-week glucocorticoid taper. Lack of evident disease activity was determined by either a score of 0 on the IgG4-RD Responder Index (score range: 0-4, with lower scores indicating better disease control) or an investigator's assessment that no disease activity was present based on physical, laboratory, pathology, or other evidence.

Outcome measures

Measure	Placebo n=67 Participants Participants with IgG4-RD were randomized to receive placebo IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation.	Inebilizumab 300 mg n=68 Participants Participants with IgG4-RD were randomized to receive inebilizumab 300 mg IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation.
RCP: Percentage of Participants Achieving Flare-free, Corticosteroid-free Complete Remission at Week 52	15 Participants	40 Participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: Safety Analysis Set RCP: All participants who received any dose of investigational product during the RCP. Participants were analyzed according to the treatment they actually received. Specifically, participants randomized to the inebilizumab group who received all placebo dose were included in the placebo group.

An adverse event (AE) referred to any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. Serious AEs (SAEs) were untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events. AEs were graded (Grade 3: severe; Grade 4: life-threatening; Grade 5: death) using the Common Terminology Criteria for Adverse Events [CTCAE]).

Outcome measures

Measure	Placebo n=67 Participants Participants with IgG4-RD were randomized to receive placebo IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation.	Inebilizumab 300 mg n=68 Participants Participants with IgG4-RD were randomized to receive inebilizumab 300 mg IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation.
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the RCP Fatal TEAEs	0 Participants	0 Participants
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the RCP Grade ≥ 3 TEAEs	8 Participants	12 Participants
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the RCP TEAEs	66 Participants	66 Participants
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the RCP SAEs	6 Participants	12 Participants

SECONDARY outcome

Timeframe: From the first dose of investigational product in OLP to the end of OLP or cutoff date; median (min, max) duration was 51.6 (0.1, 108.3) weeks.

An AE referred to any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. SAEs were untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events. AEs were graded (Grade 3: severe; Grade 4: life-threatening; Grade 5: death) using the CTCAE).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Week 52

Population: Full Analysis Set: all participants who received any dose of investigational product during the RCP.

Incidence was the proportion of the participants with ADA positive post-baseline only or boosted their preexisting ADA (at least 4-fold over the baseline titer) during the study period. Baseline was defined as the last valid value on or before the first dose of RCP.

Outcome measures

Measure	Placebo n=67 Participants Participants with IgG4-RD were randomized to receive placebo IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation.	Inebilizumab 300 mg n=68 Participants Participants with IgG4-RD were randomized to receive inebilizumab 300 mg IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation.
RCP: Number of Participants With Anti-drug Antibodies (ADA) to Inebilizumab by Week 52	5 Participants	6 Participants

SECONDARY outcome

Timeframe: Week 52

Population: Full Analysis Set: all participants who received any dose of investigational product during the RCP, and experienced IgG4-RD flares, regardless of the AC determination of flare.

Time to initiation of the first treatment (medication or procedure) for new or worsening disease activity, as determined by the investigator, within the RCP, was measured from day 1 (dosing) to the date the first treatment was administered. It Included any treatment initiated by the investigator for disease activity, regardless of the AC determination of flare.

KM method was used to estimate the median time to the initiation of first treatment or worsening of disease activity, and 95% CI.

Outcome measures

Measure	Placebo n=42 Participants Participants with IgG4-RD were randomized to receive placebo IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation.	Inebilizumab 300 mg n=7 Participants Participants with IgG4-RD were randomized to receive inebilizumab 300 mg IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation.
RCP: Time to Initiation of First Treatment for New or Worsening Disease Activity Within the RCP	237.0 Days Interval 143.0 to 310.0	NA Days Interval 371.0 to Due to insufficient number of participants initiating a new treatment or worsening disease activity, the median and upper CI were not reached using the KM method.

SECONDARY outcome

Timeframe: Week 52

Population: Full Analysis Set: all participants who received any dose of investigational product during the RCP.

The annualized flare rate for AC-determined IgG4-RD flares, whether or not treated, during the RCP was calculated by dividing the total number of AC-determined flares by the total time at risk (in years) for all participants. This measure reflected the frequency of IgG4-RD flares, irrespective of treatment, per participant per year during the study period.

Outcome measures

Measure	Placebo n=67 Participants Participants with IgG4-RD were randomized to receive placebo IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation.	Inebilizumab 300 mg n=68 Participants Participants with IgG4-RD were randomized to receive inebilizumab 300 mg IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation.
RCP: Annualized Flare Rate for AC-Determined IgG4-RD Flares at Week 52	0.75 Flares per participant per year Interval 0.57 to 0.99	0.16 Flares per participant per year Interval 0.09 to 0.29

SECONDARY outcome

Timeframe: Week 52

Population: Full Analysis Set: all participants who received any dose of investigational product during the RCP.

GC use was calculated as the cumulative glucocorticoid dose (in milligrams) taken for the purpose of IgG4-RD disease control during the RCP. This measure accounted for all GC treatments administered to participants to manage disease activity throughout the study period.

Outcome measures

Measure	Placebo n=67 Participants Participants with IgG4-RD were randomized to receive placebo IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation.	Inebilizumab 300 mg n=68 Participants Participants with IgG4-RD were randomized to receive inebilizumab 300 mg IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation.
RCP: Cumulative Glucocorticoid (GC) Use for IgG4-RD Disease Control by Week 52	1384.53 mg Standard Deviation 1723.26	118.25 mg Standard Deviation 438.97

Adverse Events

RCP: Placebo

Serious events: 6 serious events

Other events: 49 other events

Deaths: 0 deaths

RCP: Inebilizumab 300 mg

Serious events: 12 serious events

Other events: 54 other events

Deaths: 0 deaths

OLP: Inebilizumab 300 mg

Serious events: 14 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Measure	RCP: Placebo n=67 participants at risk Participants with IgG4-RD were randomized to receive placebo IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation.	RCP: Inebilizumab 300 mg n=68 participants at risk Participants with IgG4-RD were randomized to receive inebilizumab 300 mg IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP.	OLP: Inebilizumab 300 mg n=90 participants at risk Participants received inebilizumab on OLP Days 1 and 15. Participants then received inebilizumab Q6M for the duration of the OLP.
Cardiac disorders Coronary artery stenosis	1.5% 1/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Eye disorders Cataract	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Hepatobiliary disorders Hepatic function abnormal	1.5% 1/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Immune system disorders Anaphylactic reaction	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.5% 1/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Infections and infestations Appendicitis	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.5% 1/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Infections and infestations COVID-19	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.5% 1/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Infections and infestations COVID-19 pneumonia	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.5% 1/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Infections and infestations Dengue fever	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Infections and infestations Diverticulitis	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.5% 1/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Infections and infestations Febrile infection	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Infections and infestations Pneumonia	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	2.2% 2/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Injury, poisoning and procedural complications Fall	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.5% 1/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Metabolism and nutrition disorders Diabetes mellitus	1.5% 1/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Metabolism and nutrition disorders Gout	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.5% 1/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.5% 1/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.5% 1/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign ovarian tumour	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroadenomatoid mastopathy	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.5% 1/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Nervous system disorders Dizziness	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Nervous system disorders Transient ischaemic attack	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Renal and urinary disorders Acute kidney injury	1.5% 1/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.5% 1/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Respiratory, thoracic and mediastinal disorders Pulmonary atypical adenomatous hyperplasia	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.5% 1/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.5% 1/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Respiratory, thoracic and mediastinal disorders Sinus disorder	1.5% 1/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Skin and subcutaneous tissue disorders Lichen sclerosus	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Vascular disorders Deep vein thrombosis	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.5% 1/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.

Other adverse events

Measure	RCP: Placebo n=67 participants at risk Participants with IgG4-RD were randomized to receive placebo IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP. Treatment assignment was stratified based on whether the participant was newly diagnosed or had a recurrent IgG4-RD manifestation.	RCP: Inebilizumab 300 mg n=68 participants at risk Participants with IgG4-RD were randomized to receive inebilizumab 300 mg IV infusion on Day 1, Day 15, and Week 26 during the 52-week RCP.	OLP: Inebilizumab 300 mg n=90 participants at risk Participants received inebilizumab on OLP Days 1 and 15. Participants then received inebilizumab Q6M for the duration of the OLP.
Blood and lymphatic system disorders Lymphopenia	9.0% 6/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	16.2% 11/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Blood and lymphatic system disorders Neutropenia	4.5% 3/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	5.9% 4/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	3.3% 3/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Cardiac disorders Palpitations	1.5% 1/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	5.9% 4/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Gastrointestinal disorders Abdominal pain	10.4% 7/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	5.9% 4/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	3.3% 3/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Gastrointestinal disorders Abdominal pain upper	7.5% 5/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	2.9% 2/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Gastrointestinal disorders Diarrhoea	13.4% 9/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	4.4% 3/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	2.2% 2/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Gastrointestinal disorders Nausea	6.0% 4/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
General disorders Asthenia	11.9% 8/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	2.9% 2/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
General disorders Fatigue	7.5% 5/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	7.4% 5/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	4.4% 4/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
General disorders Pyrexia	4.5% 3/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	8.8% 6/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	4.4% 4/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Infections and infestations COVID-19	19.4% 13/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	22.1% 15/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	21.1% 19/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Infections and infestations Conjunctivitis	6.0% 4/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.5% 1/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	2.2% 2/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Infections and infestations Nasopharyngitis	6.0% 4/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	8.8% 6/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	5.6% 5/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Infections and infestations Sinusitis	6.0% 4/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	2.2% 2/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Infections and infestations Upper respiratory tract infection	11.9% 8/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	5.9% 4/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	11.1% 10/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Infections and infestations Urinary tract infection	6.0% 4/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	11.8% 8/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	3.3% 3/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Investigations Alanine aminotransferase increased	6.0% 4/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	2.9% 2/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Investigations Gamma-glutamyltransferase increased	4.5% 3/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	5.9% 4/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Metabolism and nutrition disorders Hyperglycaemia	7.5% 5/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.5% 1/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Musculoskeletal and connective tissue disorders Arthralgia	10.4% 7/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	5.9% 4/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	3.3% 3/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Musculoskeletal and connective tissue disorders Back pain	7.5% 5/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	8.8% 6/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	3.3% 3/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Musculoskeletal and connective tissue disorders Immunoglobulin G4 related disease	7.5% 5/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.5% 1/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	5.9% 4/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	3.3% 3/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Musculoskeletal and connective tissue disorders Pain in extremity	7.5% 5/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	2.9% 2/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	0.00% 0/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Nervous system disorders Dizziness	7.5% 5/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.5% 1/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Nervous system disorders Headache	10.4% 7/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	8.8% 6/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	3.3% 3/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Respiratory, thoracic and mediastinal disorders Cough	7.5% 5/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	4.4% 3/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	3.3% 3/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	6.0% 4/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.5% 1/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	2.2% 2/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Skin and subcutaneous tissue disorders Pruritus	9.0% 6/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	4.4% 3/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.1% 1/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.
Vascular disorders Hypertension	3.0% 2/67 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	1.5% 1/68 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.	6.7% 6/90 • For RCP mortality reporting: from randomization to the end of RCP; median (min, max) was 54.1 (2.1, 65.1) weeks. For RCP AE reporting: from Day 1 to the end of RCP or cutoff date; median (min, max) was 54.1 (2.1, 65.1) weeks. For OLP mortality and AE reporting: from the 1st dose of IP in OLP to the end of OLP or cutoff date; median (min, max) was 51.6 (0.1, 108.3) weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the study.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: medinfo@amgen.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER