Trial Outcomes & Findings for Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge Study (NCT NCT05347693)

NCT ID: NCT05347693

Last Updated: 2025-11-28

Results Overview

A response was defined as a participant having serum K+ within 3.5 and 5.0 mmol/L at 180 days post-discharge. No response was defined as a participant who: 1) used rescue therapy for hyperkalaemia (HK) during the outpatient period; 1) died prior to 180 days post-discharge; 3) were missing an assessment at visit 10; 4) were lost to follow-up prior to 180 days post-discharge; 5) down-titrated (or discontinued) RAASi. The number of participants who had a response/no response is presented.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 186 participants
• Primary outcome timeframe: At 180 days post-discharge (Visit 10)
• Results posted on: 2025-11-28

Participant Flow

A total of 186 participants were screened from 28 study sites across 6 countries.

This study consisted of 2 phases: an inpatient period and an outpatient period. Of the 186 participants enrolled in the inpatient period, 137 participants were randomized into the outpatient period (68 to Arm A and 69 to Arm B). The remaining 49 participants were not randomized due to reasons such as withdrawal of consent, failure to meet inclusion/exclusion criteria, screening failure, death, or other reasons (eg, mistaken study termination or discharged without notifying investigators).

Participant milestones

Measure	Inpatient Period Participants were treated with SZC as per local label (correction and/or maintenance treatment), starting at baseline and based on local potassium (K+) measurement obtained within 24 hours of treatment initiation.	Outpatient Period - Arm A: SZC Participants discharged with SZC, as per local label, to manage hyperkalaemia (HK) until 7 days before the end of the study.	Outpatient Period - Arm B: Standard of Care (SoC) SZC was withdrawn and participants discharged with SoC, as per local practice, to manage HK until the end of study.
Inpatient Period STARTED	186	0	0
Inpatient Period COMPLETED	137	0	0
Inpatient Period NOT COMPLETED	49	0	0
Outpatient Period STARTED	0	68	69
Outpatient Period COMPLETED	0	42	56
Outpatient Period NOT COMPLETED	0	26	13

Reasons for withdrawal

Measure	Inpatient Period Participants were treated with SZC as per local label (correction and/or maintenance treatment), starting at baseline and based on local potassium (K+) measurement obtained within 24 hours of treatment initiation.	Outpatient Period - Arm A: SZC Participants discharged with SZC, as per local label, to manage hyperkalaemia (HK) until 7 days before the end of the study.	Outpatient Period - Arm B: Standard of Care (SoC) SZC was withdrawn and participants discharged with SoC, as per local practice, to manage HK until the end of study.
Inpatient Period Participant was discharged from the hospital but did not inform the site	1	0	0
Inpatient Period Withdrawal of consent	10	0	0
Inpatient Period Failure to meet inclusion/exclusion criteria	19	0	0
Inpatient Period Screening Failure	8	0	0
Inpatient Period Death	2	0	0
Inpatient Period Physician Decision	5	0	0
Inpatient Period Adverse Event	3	0	0
Inpatient Period Withdrawn from study due to a mistaken request for study termination	1	0	0
Outpatient Period Adverse Event	0	9	0
Outpatient Period Death	0	6	2
Outpatient Period Development of study-specific withdrawal criteria: Severe HK	0	0	1
Outpatient Period Lost to Follow-up	0	0	1
Outpatient Period Participant's study compliance was impossible to monitor and they had a complex private situation.	0	1	0
Outpatient Period Scheduled hemodialysis	0	1	0
Outpatient Period Severe HK	0	0	1
Outpatient Period Started dialysis on 16 Feb 2023	0	1	0
Outpatient Period Start of dialysis	0	0	1
Outpatient Period The participant entered hemodialysis	0	0	1
Outpatient Period The participant moved to another city and could not attend the study visits	0	0	1
Outpatient Period Withdrawal by Subject	0	8	5

Baseline Characteristics

Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge Study

Baseline characteristics by cohort

Measure	Outpatient Period - Arm A: SZC n=68 Participants Participants discharged with SZC, as per local label, to manage HK until 7 days before the end of the study.	Outpatient Period - Arm B: SoC n=68 Participants SZC was withdrawn and participants discharged with SoC, as per local practice, to manage HK until the end of study.	Total n=136 Participants Total of all reporting groups
Sex: Female, Male Male	43 Participants n=30 Participants	52 Participants n=30 Participants	95 Participants n=60 Participants
Race/Ethnicity, Customized Hispanic or Latino	21 Participants n=30 Participants	10 Participants n=30 Participants	31 Participants n=60 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	43 Participants n=30 Participants	56 Participants n=30 Participants	99 Participants n=60 Participants
Race/Ethnicity, Customized Not Reported	4 Participants n=30 Participants	3 Participants n=30 Participants	7 Participants n=60 Participants
Age, Continuous	72.8 Years STANDARD_DEVIATION 10.25 • n=30 Participants	72.1 Years STANDARD_DEVIATION 10.99 • n=30 Participants	72.5 Years STANDARD_DEVIATION 10.59 • n=60 Participants
Age, Customized 18-64 years	14 Participants n=30 Participants	13 Participants n=30 Participants	27 Participants n=60 Participants
Age, Customized 65-84 years	45 Participants n=30 Participants	47 Participants n=30 Participants	92 Participants n=60 Participants
Age, Customized >=85 years	9 Participants n=30 Participants	8 Participants n=30 Participants	17 Participants n=60 Participants
Sex: Female, Male Female	25 Participants n=30 Participants	16 Participants n=30 Participants	41 Participants n=60 Participants
Race/Ethnicity, Customized White	64 Participants n=30 Participants	64 Participants n=30 Participants	128 Participants n=60 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race/Ethnicity, Customized Asian	0 Participants n=30 Participants	1 Participants n=30 Participants	1 Participants n=60 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race/Ethnicity, Customized Other	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Country Belgium	0 Participants n=30 Participants	2 Participants n=30 Participants	2 Participants n=60 Participants
Country Spain	57 Participants n=30 Participants	59 Participants n=30 Participants	116 Participants n=60 Participants
Country France	4 Participants n=30 Participants	2 Participants n=30 Participants	6 Participants n=60 Participants
Country United Kingdom	0 Participants n=30 Participants	2 Participants n=30 Participants	2 Participants n=60 Participants
Country Italy	6 Participants n=30 Participants	3 Participants n=30 Participants	9 Participants n=60 Participants
Country Netherlands	1 Participants n=30 Participants	0 Participants n=30 Participants	1 Participants n=60 Participants

PRIMARY outcome

Timeframe: At 180 days post-discharge (Visit 10)

Population: Full Analysis Set (FAS). The FAS included all randomised participants.

A response was defined as a participant having serum K+ within 3.5 and 5.0 mmol/L at 180 days post-discharge.

No response was defined as a participant who: 1) used rescue therapy for hyperkalaemia (HK) during the outpatient period; 1) died prior to 180 days post-discharge; 3) were missing an assessment at visit 10; 4) were lost to follow-up prior to 180 days post-discharge; 5) down-titrated (or discontinued) RAASi.

The number of participants who had a response/no response is presented.

Outcome measures

Measure	Arm A: SZC n=68 Participants Participants discharged with SZC, as per local label, to manage HK until 7 days before the end of the study.	Arm B: SoC n=69 Participants SZC was withdrawn and participants discharged with SoC, as per local practice, to manage HK until the end of study.
Occurrence (Yes/No) of NK (K+ Between 3.5 and 5.0 mmol/L, Inclusive) at 180 Days Post-discharge Response	21 Number of participants	25 Number of participants
Occurrence (Yes/No) of NK (K+ Between 3.5 and 5.0 mmol/L, Inclusive) at 180 Days Post-discharge No response	47 Number of participants	44 Number of participants

SECONDARY outcome

Timeframe: At any time post-discharge (from Visits 4 to 10), up to 180 days

Population: FAS. The FAS included all randomised participants.

The time to first occurrence of all-cause hospital admission, emergency department (ED) visits with HK as a contributing factor, all-cause death or use of rescue therapy for HK was calculated as date of first occurrence of (all-cause hospital admission, ED visits with HK as a contributing factor, all-cause death, use of rescue therapy for HK, date of loss to follow-up) - date of randomization + 1.

The median time to event (days) is presented.

Outcome measures

Measure	Arm A: SZC n=68 Participants Participants discharged with SZC, as per local label, to manage HK until 7 days before the end of the study.	Arm B: SoC n=69 Participants SZC was withdrawn and participants discharged with SoC, as per local practice, to manage HK until the end of study.
Time to First Occurrence of Any Component of All-cause Hospital Admissions or ED Visits With HK as a Contributing Factor, or All-cause Death, or Use of Rescue Therapy for HK at Any Time Post-discharge up to 180 Days	136 Days Interval 60.0 to Although over 50% of participants experienced an event, there were proportionally too few events to estimate an upper confidence interval for the median.	NA Days Interval 63.0 to Fewer than 50% of participants experienced an event and no median time and upper confidence interval could be calculated.

SECONDARY outcome

Timeframe: At any time post-discharge (from Visits 4 to 10), up to 180 days

Population: FAS. The FAS included all randomised participants.

The time to first occurrence of any component of all-cause hospital admission or ED visit with HK as a contributing factor at any time post-discharge up to 180 days was calculated as the earliest date of (all-cause hospital admission, ED visits with HK as a contributing factor, all-cause death, use of rescue therapy for HK, date of loss to follow-up, date of 180 days post-discharge) - date of randomization + 1.

The median time to event (days) is presented.

Outcome measures

Measure	Arm A: SZC n=68 Participants Participants discharged with SZC, as per local label, to manage HK until 7 days before the end of the study.	Arm B: SoC n=69 Participants SZC was withdrawn and participants discharged with SoC, as per local practice, to manage HK until the end of study.
Time to First Occurrence of Any Component of All-cause Hospital Admission or ED Visit With HK as a Contributing Factor at Any Time Post-discharge up to 180 Days	NA Days Interval 116.0 to Fewer than 50% of participants experienced an event and no median time and upper confidence interval could be calculated.	NA Days Interval 123.0 to Fewer than 50% of participants experienced an event and no median time and upper confidence interval could be calculated.

SECONDARY outcome

Timeframe: At any time post-discharge (from Visits 4 to 10), up to 180 days

Population: FAS. The FAS included all randomised participants.

The number of all-cause events (hospital admissions or ED visits) with HK as a contributing factor at any time post-discharge up to 180 days is presented.

Participants who discontinued treatment, used rescue therapy for HK, experienced all-cause death or loss to follow-up prior to 180 days post-discharge or who down-titrated (including discontinued) RAASi were to have all available hospital admission data used irrespective of the intercurrent event (treatment policy strategy).

Outcome measures

Measure	Arm A: SZC n=68 Participants Participants discharged with SZC, as per local label, to manage HK until 7 days before the end of the study.	Arm B: SoC n=69 Participants SZC was withdrawn and participants discharged with SoC, as per local practice, to manage HK until the end of study.
Number of All-cause Events (Hospital Admissions or ED Visits) With HK as a Contributing Factor at Any Time Post-discharge up to 180 Days	0.7 Events Standard Deviation 0.92	0.6 Events Standard Deviation 0.83

SECONDARY outcome

Timeframe: At any time post-discharge (from Visits 4 to 10), up to 180 days

Population: FAS. The FAS included all randomised participants.

The time to first occurrence of RAASi down-titration (or discontinuation) was calculated as date of first occurrence of (RAASi down-titration, all-cause death, date of loss to follow-up) - date of randomization + 1.

The median time to event (days) is presented.

Outcome measures

Measure	Arm A: SZC n=68 Participants Participants discharged with SZC, as per local label, to manage HK until 7 days before the end of the study.	Arm B: SoC n=69 Participants SZC was withdrawn and participants discharged with SoC, as per local practice, to manage HK until the end of study.
Time to First Occurrence of RAASi Down-titration (or Discontinuation) at Any Time Post-discharge up to 180 Days	NA Days Fewer than 50% of participants experienced an event and no median time, lower confidence interval, and upper confidence interval could be calculated.	NA Days Fewer than 50% of participants experienced an event and no median time, lower confidence interval, and upper confidence interval could be calculated.

SECONDARY outcome

Timeframe: At any time post-discharge (from Visits 4 to 10), up to 180 days

Population: FAS. The FAS included all randomised participants.

The time to first occurrence of hospital admission or ED visit, both with HK as a contributing factor, was calculated as date of first occurrence of (Hospital admission or ED visit with HK as a contributing factor, all-cause death, use of rescue therapy for HK, date of loss to follow-up) - date of randomization + 1.

The median time to event (days) is presented.

Outcome measures

Measure	Arm A: SZC n=68 Participants Participants discharged with SZC, as per local label, to manage HK until 7 days before the end of the study.	Arm B: SoC n=69 Participants SZC was withdrawn and participants discharged with SoC, as per local practice, to manage HK until the end of study.
Time to First Occurrence of Hospital Admission or ED Visit, Both With HK as a Contributing Factor at Any Time Post-discharge up to 180 Days	NA Days Fewer than 50% of participants experienced an event and no median time, lower confidence interval, and upper confidence interval could be calculated.	NA Days Fewer than 50% of participants experienced an event and no median time, lower confidence interval, and upper confidence interval could be calculated.

SECONDARY outcome

Timeframe: At any time post-discharge (from Visits 4 to 10), up to 180 days

Population: FAS. The FAS included all randomised participants.

The number of events (hospital admissions or ED visits) with HK as a contributing factor, at any time post-discharge up to 180 days is presented.

Participants who discontinued treatment, used rescue therapy for HK, experienced all-cause death or loss to follow-up prior to 180 days post-discharge or who downtitrated (including discontinued) RAASi were to have all available hospital admission data used irrespective of the intercurrent event (treatment policy strategy).

Outcome measures

Measure	Arm A: SZC n=68 Participants Participants discharged with SZC, as per local label, to manage HK until 7 days before the end of the study.	Arm B: SoC n=69 Participants SZC was withdrawn and participants discharged with SoC, as per local practice, to manage HK until the end of study.
Number of Events (Hospital Admissions or ED Visits) With HK as a Contributing Factor, at Any Time Post-discharge up to 180 Days	0.1 Events Standard Deviation 0.24	0.1 Events Standard Deviation 0.26

Adverse Events

Inpatient Period

Serious events: 10 serious events

Other events: 0 other events

Deaths: 2 deaths

Outpatient Period - Arm A: SZC

Serious events: 29 serious events

Other events: 22 other events

Deaths: 6 deaths

Outpatient Period - Arm B: SoC

Serious events: 21 serious events

Other events: 30 other events

Deaths: 2 deaths

Serious adverse events

Measure	Inpatient Period n=174 participants at risk Participants were treated with SZC as per local label (correction and/or maintenance treatment), starting at baseline and based on local K+ measurement obtained within 24 hours of treatment initiation.	Outpatient Period - Arm A: SZC n=68 participants at risk Participants discharged with SZC, as per local label, to manage HK until 7 days before the end of the study.	Outpatient Period - Arm B: SoC n=68 participants at risk SZC was withdrawn and participants discharged with SoC, as per local practice, to manage HK until the end of study.
Gastrointestinal disorders Diarrhoea	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Gastrointestinal disorders Enterocolitis	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Gastrointestinal disorders Gastric perforation	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
General disorders Multiple organ dysfunction syndrome	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
General disorders Oedema	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Infections and infestations Bronchitis	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Infections and infestations Covid-19	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Blood and lymphatic system disorders Anaemia	1.1% 2/174 • Number of events 2 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 2 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 2 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Infections and infestations Covid-19 pneumonia	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Infections and infestations Erysipelas	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Infections and infestations Gastroenteritis	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Infections and infestations Influenza	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Infections and infestations Lower respiratory tract infection	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Infections and infestations Penile abscess	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Infections and infestations Pneumonia	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	4.4% 3/68 • Number of events 4 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Infections and infestations Pneumonia aspiration	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Infections and infestations Sepsis	0.57% 1/174 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Infections and infestations Septic shock	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Cardiac disorders Acute myocardial infarction	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Infections and infestations Subcutaneous abscess	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Infections and infestations Urinary tract infection	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	2.9% 2/68 • Number of events 2 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Infections and infestations Urosepsis	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Investigations Electrocardiogram qt prolonged	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Vascular disorders Ischaemia	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Cardiac disorders Cardiac arrest	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	2.9% 2/68 • Number of events 2 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Nervous system disorders Cerebrovascular accident	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Nervous system disorders Epilepsy	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Nervous system disorders Ischaemic stroke	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Nervous system disorders Myasthenia gravis crisis	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Psychiatric disorders Confusional state	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Renal and urinary disorders Acute kidney injury	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	4.4% 3/68 • Number of events 3 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 2 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Renal and urinary disorders Chronic kidney disease	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	2.9% 2/68 • Number of events 2 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Cardiac disorders Cardiac failure	0.57% 1/174 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	2.9% 2/68 • Number of events 5 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	2.9% 2/68 • Number of events 3 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Reproductive system and breast disorders Male genital tract fistula	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	2.9% 2/68 • Number of events 2 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Vascular disorders Hypotension	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Vascular disorders Peripheral ischaemia	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Cardiac disorders Cardiac failure chronic	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 2 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Cardiac disorders Cardiac failure congestive	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Cardiac disorders Cardiac tamponade	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Cardiac disorders Pericarditis	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Gastrointestinal disorders Duodenal ulcer	0.57% 1/174 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.57% 1/174 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Gastrointestinal disorders Intestinal ischaemia	0.57% 1/174 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Infections and infestations Postoperative wound infection	0.57% 1/174 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penile squamous cell carcinoma	0.57% 1/174 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.57% 1/174 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Renal and urinary disorders Renal impairment	0.57% 1/174 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
General disorders Medical device site haemorrhage	0.57% 1/174 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	0.00% 0/68 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.

Other adverse events

Measure	Inpatient Period n=174 participants at risk Participants were treated with SZC as per local label (correction and/or maintenance treatment), starting at baseline and based on local K+ measurement obtained within 24 hours of treatment initiation.	Outpatient Period - Arm A: SZC n=68 participants at risk Participants discharged with SZC, as per local label, to manage HK until 7 days before the end of the study.	Outpatient Period - Arm B: SoC n=68 participants at risk SZC was withdrawn and participants discharged with SoC, as per local practice, to manage HK until the end of study.
Blood and lymphatic system disorders Anaemia	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	4.4% 3/68 • Number of events 3 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	11.8% 8/68 • Number of events 8 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Infections and infestations Urinary tract infection	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	1.5% 1/68 • Number of events 1 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	8.8% 6/68 • Number of events 8 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	17.6% 12/68 • Number of events 14 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	25.0% 17/68 • Number of events 19 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	4.4% 3/68 • Number of events 3 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	5.9% 4/68 • Number of events 4 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Renal and urinary disorders Renal impairment	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	7.4% 5/68 • Number of events 5 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	5.9% 4/68 • Number of events 4 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.
Cardiac disorders Cardiac failure	0.00% 0/174 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	5.9% 4/68 • Number of events 4 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.	2.9% 2/68 • Number of events 2 • Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months The AEs that occurred during the IP and OP are reported. IP: Safety Set Open. Of the 186 participants enrolled, 12 participants did not receive 1 dose of SZC during the IP and were excluded from the analysis. OP: Safety Set Randomized. Of the 137 participants randomized (68 to Arm A and 69 to Arm B), there was 1 participant in Arm B who did not receive treatment during the OP and was excluded from the analysis.

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Investigator shall be entitled to publish the results of, or make presentations related to, the Study, provided that any publications or presentations to be made within 2 years after completion of the Study shall require the Sponsor's prior written consent.
• Publication restrictions are in place

Restriction type: OTHER